AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
This device is manufactured by MEDTRONIC HEART VALVES DIVISION.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-29 | Injury | Heart Block | None |
| 2024-07-26 | Injury | Heart Block, Valvular Insufficiency/ Regurgitation | None |
| 2024-07-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-25 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-25 | Injury | Heart Block | None |
| 2024-07-24 | Death | Fistula, Hemorrhage/Blood Loss/Bleeding, Low Blood Pressure/ Hypotension, Rupture, Pericardial Effusion, Valvular Insufficiency/ Regurgitation | None |
| 2024-07-24 | Injury | Heart Block | None |
| 2024-07-23 | Injury | Heart Block | None |
| 2024-07-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-22 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-22 | Death | Obstruction/Occlusion | None |
| 2024-07-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-18 | Injury | Stroke/CVA | None |
| 2024-07-18 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-18 | Malfunction | Valvular Insufficiency/ Regurgitation | None |
| 2024-07-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-18 | Malfunction | None | None |
| 2024-07-17 | Injury | Valvular Insufficiency/ Regurgitation | None |
| 2024-07-16 | Injury | Non specific EKG/ECG Changes | None |
| 2024-07-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-15 | Death | Asystole, Cardiovascular Insufficiency | Patient Device Interaction Problem |
| 2024-07-15 | Injury | Heart Block, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-07-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-07-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-07-02 | Injury | Non specific EKG/ECG Changes | None |
| 2024-07-01 | Injury | Vascular Dissection | Patient Device Interaction Problem |
| 2024-06-28 | Injury | Low Blood Pressure/ Hypotension | Patient Device Interaction Problem |
| 2024-06-27 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-06-27 | Injury | Low Blood Pressure/ Hypotension, Obstruction/Occlusion, Valvular Insufficiency/ Regurgitation | Material Invagination, Perivalvular Leak, Patient Device Interaction Problem |
| 2024-06-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated, Activation Failure |
| 2024-06-25 | Death | Obstruction/Occlusion, Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Perivalvular Leak, Insufficient Information, Patient Device Interaction Problem, Central Regurgitation |
| 2024-06-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-06-24 | Injury | Cardiac Arrest, Low Blood Pressure/ Hypotension | Difficult or Delayed Positioning, Patient Device Interaction Problem |
| 2024-06-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-06-19 | Injury | Heart Block | Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-06-19 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-06-19 | Injury | Rupture | Patient Device Interaction Problem |
| 2024-06-19 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated |
| 2024-06-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-06-18 | Injury | Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Perivalvular Leak, Central Regurgitation |
| 2024-06-17 | Injury | Thrombosis/Thrombus | Gradient Increase, Patient Device Interaction Problem, Thickening of Material |
| 2024-06-17 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-06-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Activation Failure |
| 2024-06-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Difficult to Setup or Prepare, Material Twisted/Bent, Activation Failure |
| 2024-06-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-06-14 | Injury | Bradycardia, Heart Block | Patient Device Interaction Problem |
| 2024-06-13 | Injury | Prolapse | Device Dislodged or Dislocated, Activation Failure, Migration |
| 2024-06-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-06-12 | Injury | Unspecified Tissue Injury, No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated, Activation Failure |
| 2024-06-12 | Malfunction | Valvular Insufficiency/ Regurgitation | Fluid/Blood Leak, Device Dislodged or Dislocated |
| 2024-06-12 | Injury | Valvular Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | Material Invagination, Perivalvular Leak |
| 2024-06-10 | Injury | Stroke/CVA, Blurred Vision, Thromboembolism | Patient Device Interaction Problem |
| 2024-06-10 | Death | Bradycardia, Cardiac Arrest, Non specific EKG/ECG Changes, Fever, Low Blood Pressure/ Hypotension, Pneumonia, Swelling/ Edema | Insufficient Information, Patient Device Interaction Problem |
| 2024-06-09 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Patient Device Interaction Problem, Migration |
| 2024-06-07 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-06-07 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-06-07 | Injury | Stroke/CVA | Patient Device Interaction Problem |
| 2024-06-06 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-06-05 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated, Activation Failure |
| 2024-06-05 | Injury | Non specific EKG/ECG Changes, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Patient Device Interaction Problem |
| 2024-06-04 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-06-04 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-06-03 | Injury | Valvular Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | Degraded, Perivalvular Leak |
| 2024-06-03 | Injury | Obstruction/Occlusion | Patient Device Interaction Problem |
| 2024-06-03 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-06-03 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-05-31 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak |
| 2024-05-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Structural Problem |
| 2024-05-30 | Injury | Non specific EKG/ECG Changes, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Patient Device Interaction Problem |
| 2024-05-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Activation Failure |
| 2024-05-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem, Activation Failure |
| 2024-05-29 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-05-29 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-05-29 | Injury | No Clinical Signs, Symptoms or Conditions | Appropriate Term/Code Not Available, Patient Device Interaction Problem |
| 2024-05-29 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Inadequacy of Device Shape and/or Size |
| 2024-05-28 | Injury | Abdominal Pain, Hemorrhage/Blood Loss/Bleeding, Obstruction/Occlusion, Heart Block, Renal Impairment | Patient Device Interaction Problem |
| 2024-05-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-05-28 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2024-05-27 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-05-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-05-23 | Injury | Heart Failure/Congestive Heart Failure | None |
| 2024-05-23 | Death | Vascular Dissection, Pericardial Effusion, Aortic Valve Insufficiency/ Regurgitation | None |
| 2024-05-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-05-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-05-23 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-05-22 | Injury | Stroke/CVA | None |
| 2024-05-21 | Death | Cardiac Arrest, Low Blood Pressure/ Hypotension | Gradient Increase, Patient Device Interaction Problem |
| 2024-05-20 | Injury | None | Material Invagination, Patient Device Interaction Problem |
| 2024-05-20 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-05-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-05-17 | Injury | Vascular Dissection, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2024-05-17 | Injury | Calcium Deposits/Calcification, Stroke/CVA, Visual Impairment | Patient Device Interaction Problem |
| 2024-05-17 | Death | Insufficient Information | Insufficient Information |
| 2024-05-16 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2024-05-16 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-05-16 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-05-16 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-05-16 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated |
| 2024-05-15 | Death | Low Blood Pressure/ Hypotension, Asystole | Insufficient Information, Patient Device Interaction Problem |
| 2024-05-15 | Death | Low Blood Pressure/ Hypotension, Asystole | Device Dislodged or Dislocated, Insufficient Information, Patient Device Interaction Problem |
| 2024-05-14 | Injury | Non specific EKG/ECG Changes, Heart Block, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2024-05-13 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-05-13 | Injury | Unspecified Tissue Injury | Difficult or Delayed Activation, Device Dislodged or Dislocated |
| 2024-05-13 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-05-09 | Injury | Heart Failure/Congestive Heart Failure | Patient Device Interaction Problem |
| 2024-05-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-05-09 | Injury | Myocardial Infarction | Patient Device Interaction Problem |
| 2024-05-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-05-08 | Injury | Non specific EKG/ECG Changes | None |
| 2024-05-07 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-05-07 | Injury | Perforation | None |
| 2024-05-07 | Injury | Vascular Dissection | None |
| 2024-05-07 | Injury | Cardiac Arrest | None |
| 2024-05-07 | Injury | Renal Failure | None |
| 2024-05-07 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-05-07 | Injury | Stroke/CVA | None |
| 2024-05-07 | Injury | Myocardial Infarction | None |
| 2024-05-07 | Injury | Non specific EKG/ECG Changes | None |
| 2024-05-07 | Injury | Endocarditis | None |
| 2024-05-06 | Injury | No Clinical Signs, Symptoms or Conditions | Device Markings/Labelling Problem, Device Dislodged or Dislocated, No Apparent Adverse Event |
| 2024-05-04 | Injury | Non specific EKG/ECG Changes, Syncope/Fainting, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-05-02 | Injury | Valvular Insufficiency/ Regurgitation | Fluid/Blood Leak, Device Dislodged or Dislocated, Central Regurgitation |
| 2024-05-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Material Invagination |
| 2024-05-02 | Injury | None | Gradient Increase, Activation Failure |
| 2024-05-01 | Death | Cardiac Arrest, Low Blood Pressure/ Hypotension, Vascular Dissection | Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2024-05-01 | Death | Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated, Central Regurgitation |
| 2024-04-30 | Injury | Vascular Dissection, No Clinical Signs, Symptoms or Conditions | Insufficient Information, Patient Device Interaction Problem |
| 2024-04-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Packaging Problem |
| 2024-04-30 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-04-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-04-29 | Injury | Heart Failure/Congestive Heart Failure | Patient Device Interaction Problem |
| 2024-04-29 | Injury | Atrial Fibrillation, Non specific EKG/ECG Changes, Low Blood Pressure/ Hypotension, Hypovolemia | Patient Device Interaction Problem |
| 2024-04-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-04-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-04-26 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-04-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-04-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-04-25 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-04-22 | Injury | Atrial Fibrillation, Heart Failure/Congestive Heart Failure | Patient Device Interaction Problem |
| 2024-04-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-04-19 | Injury | Non specific EKG/ECG Changes | Difficult or Delayed Positioning, Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-04-19 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-04-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, No Apparent Adverse Event |
| 2024-04-18 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-04-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-04-18 | Injury | Cusp Tear, Aortic Valve Insufficiency/ Regurgitation | Gradient Increase, Material Split, Cut or Torn, Central Regurgitation |
| 2024-04-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-04-17 | Injury | Valvular Insufficiency/ Regurgitation | Gradient Increase, Perivalvular Leak, Difficult to Advance, Device Dislodged or Dislocated, Activation Failure |
| 2024-04-17 | Injury | Stroke/CVA | Patient Device Interaction Problem |
| 2024-04-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-04-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-04-16 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated, Activation Failure |
| 2024-04-15 | Injury | Non specific EKG/ECG Changes, High Blood Pressure/ Hypertension, Valvular Insufficiency/ Regurgitation | Difficult or Delayed Positioning, Gradient Increase, Perivalvular Leak, Positioning Problem, Patient Device Interaction Problem |
| 2024-04-15 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-04-15 | Injury | Non specific EKG/ECG Changes, Heart Block | Patient Device Interaction Problem |
| 2024-04-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-04-15 | Injury | Vascular Dissection | Difficult or Delayed Positioning, Patient Device Interaction Problem |
| 2024-04-13 | Injury | Stroke/CVA, Ischemia | Patient Device Interaction Problem |
| 2024-04-13 | Injury | Atrial Fibrillation, Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2024-04-11 | Injury | Cardiac Arrest, Hemorrhage/Blood Loss/Bleeding, Low Blood Pressure/ Hypotension, Perforation, Rupture, Vascular Dissection, Pericardial Effusion, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2024-04-11 | Injury | Atrial Fibrillation, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-04-11 | Injury | Non specific EKG/ECG Changes, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Adverse Event Without Identified Device or Use Problem |
| 2024-04-11 | Injury | Vascular Dissection | Patient Device Interaction Problem |
| 2024-04-11 | Injury | Stroke/CVA, Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2024-04-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-09 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-04-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-04-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Activation Failure |
| 2024-04-08 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-04-06 | Death | Atrial Fibrillation, Cardiac Arrest, Non specific EKG/ECG Changes | Insufficient Information, Patient Device Interaction Problem |
| 2024-04-06 | Death | Insufficient Information | Insufficient Information |
| 2024-04-03 | Injury | Thrombosis/Thrombus, Valvular Insufficiency/ Regurgitation | Fluid/Blood Leak, Perivalvular Leak, Patient Device Interaction Problem, Thickening of Material |
| 2024-04-03 | Injury | Obstruction/Occlusion | None |
| 2024-04-03 | Death | Respiratory Failure | Insufficient Information |
| 2024-04-02 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-04-02 | Malfunction | Heart Block | Material Invagination, Activation Failure, Patient Device Interaction Problem |
| 2024-04-02 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-04-02 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-04-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Activation Failure |
| 2024-04-02 | Injury | Heart Block | None |
| 2024-04-01 | Injury | Atrial Fibrillation, Stroke/CVA, Heart Block | None |
| 2024-04-01 | Injury | Non specific EKG/ECG Changes, Heart Block | None |
| 2024-04-01 | Injury | Anemia, Non specific EKG/ECG Changes, Hemorrhage/Blood Loss/Bleeding, Pleural Effusion, Hypervolemia, Heart Block | Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2024-04-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-01 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated |
| 2024-03-30 | Death | None | Insufficient Information, Patient Device Interaction Problem |
| 2024-03-29 | Death | Heart Failure/Congestive Heart Failure | Insufficient Information, Patient Device Interaction Problem |
| 2024-03-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-28 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-03-28 | Injury | Pneumonia | Patient Device Interaction Problem |
| 2024-03-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Activation Failure |
| 2024-03-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-03-23 | Injury | Non specific EKG/ECG Changes, Heart Block | Patient Device Interaction Problem |
| 2024-03-22 | Injury | Valvular Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-21 | Death | Cardiac Arrest, Loss of consciousness | None |
| 2024-03-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-20 | Injury | Sepsis, Vascular Dissection, No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-20 | Death | Non specific EKG/ECG Changes, No Clinical Signs, Symptoms or Conditions | Patient Device Interaction Problem, Migration |
| 2024-03-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-19 | Injury | Heart Block | None |
| 2024-03-18 | Injury | Thrombosis/Thrombus, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem, Thickening of Material |
| 2024-03-17 | Death | Insufficient Information | Insufficient Information |
| 2024-03-15 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-15 | Injury | Valvular Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-15 | Injury | Stroke/CVA, Paralysis, Swelling/ Edema | Patient Device Interaction Problem |
| 2024-03-14 | Injury | Stroke/CVA | None |
| 2024-03-14 | Injury | Heart Block | None |
| 2024-03-12 | Injury | Mitral Valve Insufficiency/ Regurgitation | None |
| 2024-03-12 | Injury | Syncope/Fainting, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-03-12 | Injury | High Blood Pressure/ Hypertension, Mitral Valve Stenosis, Pulmonary Edema, Renal Failure, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Patient Device Interaction Problem, Migration |
| 2024-03-11 | Injury | Bacteremia | Patient Device Interaction Problem |
| 2024-03-11 | Death | Pneumonia | Insufficient Information, Patient Device Interaction Problem |
| 2024-03-11 | Injury | Low Blood Pressure/ Hypotension, Pericardial Effusion, Heart Block | None |
| 2024-03-09 | Injury | Bradycardia | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-03-07 | Injury | Non specific EKG/ECG Changes, Heart Block | Patient Device Interaction Problem |
| 2024-03-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Activation Failure |
| 2024-03-07 | Injury | Heart Block | None |
| 2024-03-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-06 | Death | Stroke/CVA, Low Blood Pressure/ Hypotension, Ascites, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Appropriate Term/Code Not Available, Patient Device Interaction Problem, Central Regurgitation |
| 2024-03-04 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-03-04 | Injury | Bradycardia, Non specific EKG/ECG Changes, Low Blood Pressure/ Hypotension, Obstruction/Occlusion | Patient Device Interaction Problem |
| 2024-03-04 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-03-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-29 | Injury | Heart Failure/Congestive Heart Failure | Patient Device Interaction Problem |
| 2024-02-29 | Injury | Heart Failure/Congestive Heart Failure | Patient Device Interaction Problem |
| 2024-02-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-27 | Injury | Obstruction/Occlusion | Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2024-02-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-27 | Injury | Heart Failure/Congestive Heart Failure, Aortic Valve Insufficiency/ Regurgitation | Device Dislodged or Dislocated, Patient Device Interaction Problem, Central Regurgitation |
| 2024-02-26 | Injury | Hemorrhage/Blood Loss/Bleeding, Pericardial Effusion | Patient Device Interaction Problem |
| 2024-02-26 | Injury | Non specific EKG/ECG Changes | Inadequacy of Device Shape and/or Size, Patient Device Interaction Problem |
| 2024-02-25 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Migration |
| 2024-02-23 | Malfunction | Valvular Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | Perivalvular Leak, Activation Failure |
| 2024-02-23 | Injury | Non specific EKG/ECG Changes | None |
| 2024-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-21 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2024-02-19 | Malfunction | Valvular Insufficiency/ Regurgitation | Material Invagination, Perivalvular Leak |
| 2024-02-19 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak |
| 2024-02-16 | Injury | Stenosis, Obstruction/Occlusion | Patient Device Interaction Problem |
| 2024-02-16 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-02-15 | Injury | Vascular Dissection | Difficult or Delayed Activation, Device Dislodged or Dislocated, Activation Failure, Patient Device Interaction Problem |
| 2024-02-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-02-15 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-02-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-14 | Injury | Insufficient Information, No Clinical Signs, Symptoms or Conditions | No Apparent Adverse Event, Appropriate Term/Code Not Available |
| 2024-02-13 | Injury | Heart Failure/Congestive Heart Failure, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Patient Device Interaction Problem |
| 2024-02-13 | Injury | Stroke/CVA, Non specific EKG/ECG Changes, Hematoma, Hemorrhage/Blood Loss/Bleeding, Paralysis, Obstruction/Occlusion, Pseudoaneurysm | None |
| 2024-02-12 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated |
| 2024-02-09 | Injury | Atrial Fibrillation, Cardiomyopathy, Non specific EKG/ECG Changes, Tachycardia, Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-02-09 | Injury | Atrial Fibrillation, Tachycardia | Patient Device Interaction Problem |
| 2024-02-08 | Death | Low Blood Pressure/ Hypotension, Heart Failure/Congestive Heart Failure, Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Fluid/Blood Leak, Patient Device Interaction Problem, Central Regurgitation |
| 2024-02-08 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-02-08 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-02-08 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-02-08 | Injury | Heart Block | None |
| 2024-02-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-08 | Injury | Obstruction/Occlusion | Patient Device Interaction Problem |
| 2024-02-07 | Malfunction | Non specific EKG/ECG Changes | Material Invagination, Patient Device Interaction Problem |
| 2024-02-07 | Injury | Stroke/CVA | Patient Device Interaction Problem |
| 2024-02-07 | Injury | Rupture, Vascular Dissection, No Clinical Signs, Symptoms or Conditions | Difficult or Delayed Positioning, Gradient Increase, Device Dislodged or Dislocated, Activation Failure, Patient Device Interaction Problem |
| 2024-02-07 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-02-07 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-02-07 | Death | Insufficient Information | None |
| 2024-02-07 | Injury | Stroke/CVA, Vascular Dissection, No Clinical Signs, Symptoms or Conditions | Difficult or Delayed Positioning, Failure to Advance, Difficult or Delayed Activation, Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2024-02-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-02-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Adverse Event Without Identified Device or Use Problem |
| 2024-02-06 | Injury | Non specific EKG/ECG Changes | Insufficient Information |
| 2024-02-06 | Death | Insufficient Information | Insufficient Information |
| 2024-02-06 | Injury | Cardiac Tamponade | Insufficient Information |
| 2024-02-06 | Injury | Myocardial Infarction | Insufficient Information |
| 2024-02-06 | Injury | Hemorrhage/Blood Loss/Bleeding | Insufficient Information |
| 2024-02-06 | Death | Stroke/CVA | Insufficient Information |
| 2024-02-06 | Death | Heart Failure/Congestive Heart Failure | Insufficient Information |
| 2024-02-06 | Death | Hemorrhage/Blood Loss/Bleeding | Insufficient Information |
| 2024-02-06 | Death | Myocardial Infarction | Insufficient Information |
| 2024-02-06 | Death | Insufficient Information | Insufficient Information |
| 2024-02-06 | Injury | Aortic Valve Insufficiency/ Regurgitation | Fluid/Blood Leak |
| 2024-02-06 | Injury | Thrombosis/Thrombus | Insufficient Information |
| 2024-02-06 | Injury | Aortic Valve Stenosis | Device Stenosis |
| 2024-02-06 | Injury | Insufficient Information | Insufficient Information |
| 2024-02-06 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-02-06 | Injury | Insufficient Information | Insufficient Information |
| 2024-02-06 | Injury | Insufficient Information | Device Dislodged or Dislocated |
| 2024-02-06 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak |
| 2024-02-06 | Injury | Insufficient Information | Insufficient Information |
| 2024-02-06 | Injury | Insufficient Information | Appropriate Term/Code Not Available |
| 2024-02-06 | Injury | Rupture | Insufficient Information |
| 2024-02-06 | Injury | Insufficient Information | Migration |
| 2024-02-06 | Injury | Low Blood Pressure/ Hypotension, Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Fluid/Blood Leak, Material Invagination, Perivalvular Leak, Device Dislodged or Dislocated, Activation Failure, Patient Device Interaction Problem |
| 2024-02-06 | Injury | Stroke/CVA, Non specific EKG/ECG Changes, Paralysis, Heart Block | Patient Device Interaction Problem |
| 2024-02-05 | Injury | Non specific EKG/ECG Changes, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Patient Device Interaction Problem |
| 2024-02-05 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2024-02-05 | Injury | Non specific EKG/ECG Changes, Syncope/Fainting | None |
| 2024-02-05 | Death | Fever, Aspiration Pneumonitis | Insufficient Information |
| 2024-02-04 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-02-03 | Death | Cardiogenic Shock | None |
| 2024-01-31 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2024-01-31 | Death | Cardiac Arrest | Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2024-01-31 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-01-29 | Injury | Heart Failure/Congestive Heart Failure, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Patient Device Interaction Problem, Migration |
| 2024-01-29 | Injury | Stroke/CVA, Visual Impairment | None |
| 2024-01-26 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-01-24 | Injury | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-01-24 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-01-24 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-01-23 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult or Delayed Positioning, Material Invagination, Malposition of Device, Device Dislodged or Dislocated |
| 2024-01-23 | Injury | Non specific EKG/ECG Changes, Low Blood Pressure/ Hypotension, Obstruction/Occlusion | Patient Device Interaction Problem |
| 2024-01-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-01-23 | Injury | Low Blood Pressure/ Hypotension | Difficult or Delayed Positioning, Material Invagination, Patient Device Interaction Problem |
| 2024-01-23 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2024-01-23 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-01-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-01-22 | Injury | Obstruction/Occlusion | Patient Device Interaction Problem |
| 2024-01-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-01-20 | Death | Intracranial Hemorrhage, Muscle Weakness/Atrophy, Neuropathy, Pain | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-01-20 | Injury | Stroke/CVA, Muscle Weakness/Atrophy, Lethargy, Hemorrhagic Stroke | Insufficient Information, Patient Device Interaction Problem |
| 2024-01-19 | Injury | Non specific EKG/ECG Changes, Dizziness | Patient Device Interaction Problem |
| 2024-01-18 | Injury | Non specific EKG/ECG Changes, Heart Block | None |
| 2024-01-18 | Injury | Stroke/CVA, Loss of Vision | None |
| 2024-01-17 | Injury | Heart Failure/Congestive Heart Failure, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Patient Device Interaction Problem |
| 2024-01-17 | Injury | Atrial Fibrillation, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-01-17 | Injury | Atrial Fibrillation, Heart Block | Patient Device Interaction Problem |
| 2024-01-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-01-16 | Injury | Stroke/CVA, Dyspnea, Paralysis, Vascular Dissection, No Clinical Signs, Symptoms or Conditions | Patient Device Interaction Problem |
| 2024-01-16 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2024-01-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-01-12 | Injury | Atrial Fibrillation | Material Invagination, Patient Device Interaction Problem |
| 2024-01-12 | Injury | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-01-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Activation Failure |
| 2024-01-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-01-10 | Injury | Bradycardia, Tachycardia, Heart Block | None |
| 2024-01-10 | Injury | No Clinical Signs, Symptoms or Conditions | Malposition of Device |
| 2024-01-10 | Injury | Heart Block | Patient Device Interaction Problem |
| 2024-01-09 | Injury | Non specific EKG/ECG Changes, Heart Block | Patient Device Interaction Problem |
| 2024-01-09 | Injury | Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Material Invagination, Perivalvular Leak, No Apparent Adverse Event, Activation Failure |
| 2024-01-07 | Injury | Chest Pain, Cardiac Enzyme Elevation, Urinary Tract Infection, Renal Impairment | Patient Device Interaction Problem |
| 2024-01-05 | Injury | Heart Failure/Congestive Heart Failure | None |
| 2024-01-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2024-01-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-12-31 | Death | Heart Failure/Congestive Heart Failure | None |
| 2023-12-29 | Injury | Stroke/CVA, Muscle Weakness/Atrophy | Patient Device Interaction Problem |
| 2023-12-28 | Injury | Valvular Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-28 | Injury | Stroke/CVA | Patient Device Interaction Problem |
| 2023-12-27 | Injury | Unspecified Tissue Injury | Device Dislodged or Dislocated |
| 2023-12-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-27 | Death | Pneumonia, Heart Failure/Congestive Heart Failure, Aortic Valve Insufficiency/ Regurgitation | Material Invagination, Patient Device Interaction Problem, Central Regurgitation |
| 2023-12-27 | Death | Endocarditis, Fever, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-12-27 | Injury | Stroke/CVA, Visual Impairment, Dysphasia, Confusion/ Disorientation | Patient Device Interaction Problem |
| 2023-12-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-25 | Injury | Heart Block | None |
| 2023-12-23 | Death | Sepsis | Insufficient Information |
| 2023-12-23 | Death | Endocarditis, Heart Failure/Congestive Heart Failure, Renal Impairment | Insufficient Information, Patient Device Interaction Problem |
| 2023-12-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-21 | Injury | Heart Block | None |
| 2023-12-21 | Injury | Non specific EKG/ECG Changes | None |
| 2023-12-20 | Injury | Low Blood Pressure/ Hypotension, Cardiovascular Insufficiency, Valvular Insufficiency/ Regurgitation | None |
| 2023-12-18 | Injury | Heart Block, Valvular Insufficiency/ Regurgitation | None |
| 2023-12-14 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2023-12-13 | Injury | Valvular Insufficiency/ Regurgitation | Central Regurgitation |
| 2023-12-12 | Injury | Muscle Weakness/Atrophy, Paralysis, Vascular Dissection, Cardiovascular Insufficiency | Patient Device Interaction Problem |
| 2023-12-11 | Injury | Heart Block | None |
| 2023-12-11 | Injury | Stroke/CVA, Dysphasia, Embolism/Embolus, Diplopia/Double Vision | None |
| 2023-12-08 | Injury | Non specific EKG/ECG Changes | None |
| 2023-12-07 | Injury | Non specific EKG/ECG Changes | Device Markings/Labelling Problem, Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-12-07 | Injury | Stroke/CVA | Patient Device Interaction Problem |
| 2023-12-07 | Injury | Heart Block | None |
| 2023-12-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Gradient Increase, Activation Failure |
| 2023-12-06 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-12-05 | Injury | Non specific EKG/ECG Changes | None |
| 2023-12-01 | Injury | Non specific EKG/ECG Changes, Heart Block | Patient Device Interaction Problem |
| 2023-11-24 | Injury | Obstruction/Occlusion, Heart Block, Cardiovascular Insufficiency | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-11-24 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-11-23 | Death | Insufficient Information | Insufficient Information |
| 2023-11-20 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-11-17 | Injury | Thrombosis/Thrombus | Patient Device Interaction Problem |
| 2023-11-16 | Injury | Non specific EKG/ECG Changes, Heart Block | Patient Device Interaction Problem |
| 2023-11-16 | Injury | Heart Failure/Congestive Heart Failure, Valvular Insufficiency/ Regurgitation, Mitral Valve Insufficiency/ Regurgitation, Tricuspid Valve Insufficiency/ Regurgitation | None |
| 2023-11-16 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-11-14 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-11-13 | Injury | Stroke/CVA | Patient Device Interaction Problem |
| 2023-11-13 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Markings/Labelling Problem, Device Dislodged or Dislocated |
| 2023-11-13 | Death | Calcium Deposits/Calcification, Great Vessel Perforation, Vascular Dissection, Pericardial Effusion | Activation Failure, Patient Device Interaction Problem |
| 2023-11-08 | Injury | Rupture | Patient Device Interaction Problem |
| 2023-11-08 | Injury | Insufficient Information | Migration |
| 2023-11-08 | Injury | Cardiac Tamponade | Patient Device Interaction Problem |
| 2023-11-08 | Injury | Insufficient Information | Appropriate Term/Code Not Available |
| 2023-11-08 | Death | Cardiac Arrest | Insufficient Information |
| 2023-11-08 | Injury | Insufficient Information | Insufficient Information |
| 2023-11-08 | Injury | Insufficient Information | Device Dislodged or Dislocated |
| 2023-11-08 | Injury | Insufficient Information | Insufficient Information |
| 2023-11-08 | Injury | Insufficient Information | Insufficient Information |
| 2023-11-08 | Injury | Transient Ischemic Attack | Insufficient Information |
| 2023-11-08 | Injury | Cardiovascular Insufficiency | Insufficient Information |
| 2023-11-08 | Injury | Hemorrhage/Blood Loss/Bleeding | Insufficient Information |
| 2023-11-08 | Death | Stroke/CVA | Insufficient Information |
| 2023-11-08 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak |
| 2023-11-08 | Death | Hemorrhage/Blood Loss/Bleeding | Insufficient Information |
| 2023-11-08 | Death | Myocardial Infarction | Insufficient Information |
| 2023-11-08 | Death | Insufficient Information | Insufficient Information |
| 2023-11-08 | Injury | Aortic Valve Insufficiency/ Regurgitation | Fluid/Blood Leak |
| 2023-11-08 | Injury | Insufficient Information | Insufficient Information |
| 2023-11-08 | Injury | Thrombosis/Thrombus | Insufficient Information |
| 2023-11-08 | Injury | Aortic Valve Stenosis | Device Stenosis |
| 2023-11-08 | Death | Heart Failure/Congestive Heart Failure | Insufficient Information |
| 2023-11-08 | Death | Insufficient Information | Insufficient Information |
| 2023-11-07 | Injury | Atrial Fibrillation | Patient Device Interaction Problem |
| 2023-11-07 | Injury | Stroke/CVA, Vascular Dissection | Patient Device Interaction Problem |
| 2023-11-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-11-07 | Injury | Heart Failure/Congestive Heart Failure, Valvular Insufficiency/ Regurgitation, Mitral Valve Insufficiency/ Regurgitation, Tricuspid Valve Insufficiency/ Regurgitation | Perivalvular Leak, Patient Device Interaction Problem, Central Regurgitation |
| 2023-11-06 | Injury | Stroke/CVA, Heart Block | Patient Device Interaction Problem |
| 2023-11-02 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Activation Failure |
| 2023-11-02 | Injury | Cardiomyopathy, Tachycardia, Heart Block | Patient Device Interaction Problem |
| 2023-11-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Perivalvular Leak |
| 2023-11-01 | Injury | Obstruction/Occlusion, No Clinical Signs, Symptoms or Conditions | Malposition of Device, Device Dislodged or Dislocated, Activation Failure, Patient Device Interaction Problem, Migration |
| 2023-11-01 | Injury | Stroke/CVA, Non specific EKG/ECG Changes, Vascular Dissection, Insufficient Information | Device Dislodged or Dislocated, Insufficient Information, Activation Failure, Patient Device Interaction Problem |
| 2023-11-01 | Death | Stroke/CVA, Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem, Insufficient Information, Patient Device Interaction Problem |
| 2023-11-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | No Apparent Adverse Event, Inaccurate Information |
| 2023-10-31 | Injury | Stroke/CVA, Convulsion/Seizure, Swelling/ Edema | None |
| 2023-10-30 | Death | Heart Block, Heart Failure/Congestive Heart Failure | Patient Device Interaction Problem |
| 2023-10-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-10-26 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-10-25 | Death | Bradycardia, Pleural Effusion, Heart Failure/Congestive Heart Failure | None |
| 2023-10-25 | Death | Low Blood Pressure/ Hypotension, Sepsis, Increased Respiratory Rate | None |
| 2023-10-23 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-10-23 | Injury | Non specific EKG/ECG Changes | None |
| 2023-10-23 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-10-23 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2023-10-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-10-23 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-10-20 | Injury | Thrombosis/Thrombus | Patient Device Interaction Problem |
| 2023-10-20 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated |
| 2023-10-19 | Death | Cardiac Arrest, Low Blood Pressure/ Hypotension, Ventricular Fibrillation, Pericardial Effusion | Patient Device Interaction Problem |
| 2023-10-19 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak |
| 2023-10-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inaccurate Information |
| 2023-10-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-10-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-10-15 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-10-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-10-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-10-09 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-10-09 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-10-09 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-10-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-10-08 | Injury | Atrial Fibrillation, Bradycardia | Patient Device Interaction Problem |
| 2023-10-07 | Injury | Stroke/CVA, Hypersensitivity/Allergic reaction, Speech Disorder, Embolism/Embolus, Thrombosis/Thrombus | Patient Device Interaction Problem, Thickening of Material |
| 2023-10-06 | Injury | Diminished Pulse Pressure, Heart Block, Heart Failure/Congestive Heart Failure | Patient Device Interaction Problem |
| 2023-10-05 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-10-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-10-05 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak |
| 2023-10-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-10-04 | Injury | Cardiovascular Insufficiency, Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Material Invagination, Perivalvular Leak, Material Split, Cut or Torn, Central Regurgitation |
| 2023-10-04 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-10-04 | Injury | Weight Changes, Pericardial Effusion, Decreased Appetite | Patient Device Interaction Problem |
| 2023-10-03 | Injury | Arrhythmia, Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated, Central Regurgitation |
| 2023-10-03 | Injury | Stroke/CVA, Speech Disorder | Patient Device Interaction Problem |
| 2023-10-03 | Injury | Heart Block | Patient Device Interaction Problem |
| 2023-10-02 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-10-02 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-09-29 | Injury | Stroke/CVA, Paresis, Dysphasia, Obstruction/Occlusion | Patient Device Interaction Problem |
| 2023-09-29 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-09-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-09-28 | Death | Stroke/CVA, Obstruction/Occlusion | Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2023-09-28 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated |
| 2023-09-27 | Injury | Low Blood Pressure/ Hypotension, Tachycardia | Patient Device Interaction Problem |
| 2023-09-27 | Injury | Atrial Fibrillation, Atrial Flutter, Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-09-26 | Death | Myocardial Infarction, Obstruction/Occlusion | Patient Device Interaction Problem |
| 2023-09-25 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2023-09-25 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-09-22 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-09-18 | Injury | Insufficient Information | Insufficient Information |
| 2023-09-15 | Injury | Stroke/CVA, Dysphasia, Valvular Insufficiency/ Regurgitation | None |
| 2023-09-14 | Death | Insufficient Information | Insufficient Information |
| 2023-09-13 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-09-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-09-12 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Malposition of Device |
| 2023-09-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-09-12 | Injury | Non specific EKG/ECG Changes, Pleural Effusion, Heart Block, Heart Failure/Congestive Heart Failure | Patient Device Interaction Problem |
| 2023-09-08 | Injury | Bradycardia, Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-09-08 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-09-08 | Injury | Heart Block | Patient Device Interaction Problem |
| 2023-09-07 | Injury | Aortic Valve Insufficiency/ Regurgitation | Device Dislodged or Dislocated |
| 2023-09-07 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-09-07 | Injury | Valvular Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | Perivalvular Leak, Device Dislodged or Dislocated |
| 2023-09-05 | Injury | Non specific EKG/ECG Changes, Low Blood Pressure/ Hypotension, Hypoxia, Aortic Valve Insufficiency/ Regurgitation | Backflow, Perivalvular Leak |
| 2023-09-05 | Death | Hematoma, Low Blood Pressure/ Hypotension, Myocardial Infarction, Nausea, Dizziness, Obstruction/Occlusion | Patient Device Interaction Problem |
| 2023-09-05 | Injury | Heart Failure/Congestive Heart Failure | Patient Device Interaction Problem |
| 2023-09-05 | Death | Hemorrhage/Blood Loss/Bleeding, Intracranial Hemorrhage | None |
| 2023-08-31 | Malfunction | Insufficient Information, No Clinical Signs, Symptoms or Conditions | Material Invagination, Insufficient Information |
| 2023-08-30 | Injury | Anemia, Dyspnea, Non specific EKG/ECG Changes, Fever, High Blood Pressure/ Hypertension, Pleural Effusion, Renal Failure, Sepsis, Tachycardia, Urinary Tract Infection, Respiratory Failure, Pericardial Effusion, Heart Block, Valvular Insufficiency/ Regurgitation | Adverse Event Without Identified Device or Use Problem |
| 2023-08-30 | Injury | Heart Failure/Congestive Heart Failure | Patient Device Interaction Problem |
| 2023-08-29 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem |
| 2023-08-29 | Injury | Stroke/CVA, Paresis | Patient Device Interaction Problem |
| 2023-08-25 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-08-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-08-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-08-23 | Injury | Stenosis | Adverse Event Without Identified Device or Use Problem |
| 2023-08-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-08-22 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-08-21 | Injury | Arrhythmia, Bradycardia, Dyspnea | Patient Device Interaction Problem |
| 2023-08-21 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-08-21 | Injury | Cardiac Arrest, Low Blood Pressure/ Hypotension, Aortic Valve Insufficiency/ Regurgitation | Material Invagination, Patient Device Interaction Problem, Central Regurgitation |
| 2023-08-19 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Migration |
| 2023-08-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-08-18 | Injury | Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Backflow, Fluid/Blood Leak, Device Dislodged or Dislocated |
| 2023-08-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-08-17 | Death | Anemia, Disseminated Intravascular Coagulation (DIC), Hemoptysis, Hemorrhage/Blood Loss/Bleeding, Low Blood Pressure/ Hypotension, Pulmonary Edema, Cardiogenic Shock, Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Fluid/Blood Leak, Perivalvular Leak, Difficult to Advance, Patient Device Interaction Problem |
| 2023-08-16 | Death | Low Blood Pressure/ Hypotension, Ventricular Fibrillation, Thrombosis/Thrombus, Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2023-08-16 | Injury | Bacterial Infection | Patient Device Interaction Problem |
| 2023-08-15 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Device Dislodged or Dislocated |
| 2023-08-14 | Injury | Heart Block | None |
| 2023-08-14 | Injury | Thrombosis/Thrombus, Aortic Valve Insufficiency/ Regurgitation | Perivalvular Leak, Patient Device Interaction Problem |
| 2023-08-14 | Injury | Intracranial Hemorrhage, Paralysis | Patient Device Interaction Problem |
| 2023-08-11 | Malfunction | Low Blood Pressure/ Hypotension, No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-08-09 | Injury | Atrial Fibrillation, Stroke/CVA, Non specific EKG/ECG Changes, Muscle Weakness/Atrophy | Adverse Event Without Identified Device or Use Problem |
| 2023-08-08 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-08-07 | Injury | Low Blood Pressure/ Hypotension | Adverse Event Without Identified Device or Use Problem |
| 2023-08-07 | Injury | Stroke/CVA, Paralysis | None |
| 2023-08-07 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-08-07 | Injury | Myocardial Infarction | Insufficient Information |
| 2023-08-07 | Injury | Hemorrhage/Blood Loss/Bleeding | Insufficient Information |
| 2023-08-07 | Death | Heart Failure/Congestive Heart Failure | Insufficient Information |
| 2023-08-07 | Death | Hemorrhage/Blood Loss/Bleeding | Insufficient Information |
| 2023-08-07 | Death | Insufficient Information | Insufficient Information |
| 2023-08-07 | Death | Myocardial Infarction | Insufficient Information |
| 2023-08-07 | Injury | Non specific EKG/ECG Changes | Insufficient Information |
| 2023-08-07 | Injury | Insufficient Information | Insufficient Information |
| 2023-08-07 | Death | Cardiac Arrest | Insufficient Information |
| 2023-08-07 | Death | Pulmonary Dysfunction | Insufficient Information |
| 2023-08-07 | Death | Unspecified Nervous System Problem | Insufficient Information |
| 2023-08-07 | Injury | Insufficient Information | Device Dislodged or Dislocated |
| 2023-08-07 | Injury | Insufficient Information | Insufficient Information |
| 2023-08-07 | Death | Stroke/CVA | Insufficient Information |
| 2023-08-01 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-08-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-08-01 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-07-31 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-07-31 | Injury | Heart Block | Patient Device Interaction Problem |
| 2023-07-30 | Death | Heart Failure/Congestive Heart Failure | Insufficient Information, Patient Device Interaction Problem |
| 2023-07-28 | Death | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2023-07-28 | Death | Insufficient Information | None |
| 2023-07-27 | Injury | Aortic Valve Insufficiency/ Regurgitation | Backflow |
| 2023-07-27 | Injury | Stroke/CVA, Ambulation Difficulties, Speech Disorder | Adverse Event Without Identified Device or Use Problem |
| 2023-07-27 | Injury | Insufficient Information, No Clinical Signs, Symptoms or Conditions | Malposition of Device, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem, Activation Failure |
| 2023-07-27 | Injury | Cardiac Arrest, Non specific EKG/ECG Changes, Heart Failure/Congestive Heart Failure, Aortic Valve Insufficiency/ Regurgitation | Fluid/Blood Leak, Patient Device Interaction Problem |
| 2023-07-26 | Injury | Arrhythmia | Patient Device Interaction Problem |
| 2023-07-25 | Injury | Non specific EKG/ECG Changes, Heart Block | Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2023-07-24 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-07-24 | Injury | Dysphagia/ Odynophagia, Myocardial Infarction | Patient Device Interaction Problem |
| 2023-07-21 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-07-19 | Death | Heart Failure/Congestive Heart Failure | Insufficient Information, Patient Device Interaction Problem |
| 2023-07-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-07-18 | Injury | Heart Block | Patient Device Interaction Problem |
| 2023-07-17 | Malfunction | Pericardial Effusion | Material Invagination |
| 2023-07-16 | Injury | Bradycardia, Stroke/CVA, Loss of consciousness, Obstruction/Occlusion | Patient Device Interaction Problem |
| 2023-07-14 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem |
| 2023-07-14 | Injury | Stroke/CVA, Dysphagia/ Odynophagia, Paralysis, Cognitive Changes, Thrombosis/Thrombus, Heart Block, Heart Failure/Congestive Heart Failure, No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem, Positioning Problem |
| 2023-07-14 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem |
| 2023-07-13 | Injury | Cardiac Arrest, Low Blood Pressure/ Hypotension | Material Invagination, Adverse Event Without Identified Device or Use Problem |
| 2023-07-12 | Injury | Vascular Dissection | Failure to Advance, Device Dislodged or Dislocated |
| 2023-07-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-07-12 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem |
| 2023-07-11 | Injury | Heart Block | Patient Device Interaction Problem |
| 2023-07-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-07-11 | Malfunction | Low Blood Pressure/ Hypotension | Material Invagination |
| 2023-07-10 | Death | Vascular Dissection | Migration |
| 2023-07-10 | Injury | Stroke/CVA, Non specific EKG/ECG Changes, Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Gradient Increase, Perivalvular Leak, Device Dislodged or Dislocated |
| 2023-07-10 | Injury | Stroke/CVA, Dysphasia | Adverse Event Without Identified Device or Use Problem |
| 2023-07-08 | Death | Heart Failure/Congestive Heart Failure | Insufficient Information, Patient Device Interaction Problem |
| 2023-07-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-07-05 | Injury | Cardiac Arrest, Low Blood Pressure/ Hypotension, Tachycardia, Mitral Valve Insufficiency/ Regurgitation | Adverse Event Without Identified Device or Use Problem |
| 2023-07-05 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-07-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-07-03 | Injury | Heart Block | None |
| 2023-07-03 | Malfunction | Heart Block | Material Invagination |
| 2023-07-03 | Injury | Abdominal Pain, Fever, Urinary Tract Infection, Thromboembolism | Adverse Event Without Identified Device or Use Problem |
| 2023-06-30 | Injury | Obstruction/Occlusion, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-30 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-06-28 | Injury | Non specific EKG/ECG Changes, Heart Block | Patient Device Interaction Problem |
| 2023-06-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Fracture |
| 2023-06-26 | Injury | Non specific EKG/ECG Changes, Cancer | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-06-23 | Injury | Atrial Fibrillation, Stroke/CVA, Paralysis, Dysphasia | Adverse Event Without Identified Device or Use Problem |
| 2023-06-23 | Injury | Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Failure to Advance, Device Dislodged or Dislocated |
| 2023-06-22 | Injury | Insufficient Information | Inadequacy of Device Shape and/or Size, Device Dislodged or Dislocated |
| 2023-06-22 | Injury | Stroke/CVA, Paresis | Adverse Event Without Identified Device or Use Problem |
| 2023-06-21 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-06-20 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-06-20 | Death | Headache, Intracranial Hemorrhage, High Blood Pressure/ Hypertension, Respiratory Insufficiency | Adverse Event Without Identified Device or Use Problem |
| 2023-06-20 | Other | No Clinical Signs, Symptoms or Conditions | Material Twisted/Bent, Activation Problem |
| 2023-06-20 | Injury | Stroke/CVA, Dizziness | Adverse Event Without Identified Device or Use Problem |
| 2023-06-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Inaccurate Information |
| 2023-06-19 | Injury | Bradycardia, Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-06-19 | Injury | Heart Block, Valvular Insufficiency/ Regurgitation | Adverse Event Without Identified Device or Use Problem |
| 2023-06-17 | Injury | Pneumothorax | Appropriate Term/Code Not Available |
| 2023-06-15 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-06-15 | Injury | Valvular Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-06-15 | Injury | Heart Block | Patient Device Interaction Problem |
| 2023-06-13 | Injury | Hemorrhage/Blood Loss/Bleeding, Heart Block, Aortic Valve Insufficiency/ Regurgitation | Difficult or Delayed Positioning, Gradient Increase, Perivalvular Leak, Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-06-13 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-06-12 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-06-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-06-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-06-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-06-07 | Injury | Cardiogenic Shock | Adverse Event Without Identified Device or Use Problem |
| 2023-06-07 | Death | Hemorrhage/Blood Loss/Bleeding, Great Vessel Perforation | Patient-Device Incompatibility |
| 2023-06-07 | Death | Cardiac Arrest, Tachycardia, Urinary Tract Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-06-06 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-06-06 | Injury | Valvular Insufficiency/ Regurgitation, Insufficient Information | Backflow, Perivalvular Leak, Insufficient Information |
| 2023-06-06 | Injury | Atrial Fibrillation | Patient Device Interaction Problem |
| 2023-05-30 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-05-30 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-05-29 | Injury | Stroke/CVA, Paralysis, Dysphasia, Obstruction/Occlusion, Embolism/Embolus | Patient Device Interaction Problem |
| 2023-05-26 | Death | Non specific EKG/ECG Changes, Rupture, Insufficient Information | None |
| 2023-05-25 | Injury | Unspecified Tissue Injury | Patient Device Interaction Problem |
| 2023-05-24 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-05-24 | Injury | Non specific EKG/ECG Changes, Endocarditis, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-05-23 | Injury | Thrombosis/Thrombus | Material Integrity Problem |
| 2023-05-20 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-05-18 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-05-17 | Injury | No Clinical Signs, Symptoms or Conditions | Malposition of Device, Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2023-05-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-05-16 | Injury | Insufficient Information, No Clinical Signs, Symptoms or Conditions | No Apparent Adverse Event, Insufficient Information |
| 2023-05-16 | Death | Low Blood Pressure/ Hypotension, Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2023-05-16 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-05-15 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-05-11 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-05-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-05-09 | Injury | Stroke/CVA, Paralysis, Thromboembolism | Patient Device Interaction Problem |
| 2023-05-04 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult or Delayed Positioning, Malposition of Device, Device Dislodged or Dislocated |
| 2023-05-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-04-26 | Injury | Vascular Dissection, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Failure to Advance, Device Dislodged or Dislocated |
| 2023-04-25 | Death | Bradycardia, Heart Block | Insufficient Information, Patient Device Interaction Problem |
| 2023-04-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-04-20 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2023-04-20 | Injury | Bradycardia | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-04-13 | Injury | Arrhythmia, Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-04-12 | Injury | Stroke/CVA, Cardiac Tamponade, Cardiogenic Shock, Vascular Dissection | None |
| 2023-04-05 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-04-05 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-04-03 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-03-31 | Injury | Non specific EKG/ECG Changes, Heart Block | Patient Device Interaction Problem |
| 2023-03-31 | Injury | Non specific EKG/ECG Changes | None |
| 2023-03-31 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2023-03-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-03-27 | Injury | No Clinical Signs, Symptoms or Conditions | Inadequacy of Device Shape and/or Size, Device Dislodged or Dislocated |
| 2023-03-23 | Injury | Stroke/CVA, Paresis, Decreased Level of Consciousness | Patient Device Interaction Problem |
| 2023-03-20 | Injury | Valvular Insufficiency/ Regurgitation | Device Dislodged or Dislocated, Activation Failure |
| 2023-03-19 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-03-17 | Injury | Heart Block | None |
| 2023-03-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Activation Failure |
| 2023-03-14 | Death | Heart Failure/Congestive Heart Failure, Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Perivalvular Leak, Migration |
| 2023-03-14 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-03-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-03-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-03-09 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-03-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination, Activation Failure |
| 2023-03-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Invagination |
| 2023-03-03 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-03-01 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-02-27 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem |
| 2023-02-23 | Injury | Heart Block | None |
| 2023-02-22 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2023-02-17 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem |
| 2023-02-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Markings/Labelling Problem, No Apparent Adverse Event |
| 2023-01-26 | Injury | Low Blood Pressure/ Hypotension | Gradient Increase, Device Dislodged or Dislocated |
| 2023-01-26 | Injury | Valvular Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | Perivalvular Leak, Device Dislodged or Dislocated |
| 2023-01-24 | Death | Cardiac Arrest, Stroke/CVA, Muscle Weakness/Atrophy, Cardiogenic Shock | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2023-01-23 | Injury | Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2023-01-20 | Injury | Stroke/CVA, Lethargy, Valvular Insufficiency/ Regurgitation | Perivalvular Leak, Adverse Event Without Identified Device or Use Problem |
| 2023-01-19 | Injury | Valvular Insufficiency/ Regurgitation, Aortic Valve Insufficiency/ Regurgitation | Perivalvular Leak |
| 2023-01-10 | Injury | Atrial Fibrillation, Non specific EKG/ECG Changes, Cardiac Enzyme Elevation, Nausea, Dizziness, Syncope/Fainting, Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2023-01-05 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2022-12-22 | Injury | None | Device Dislodged or Dislocated |
| 2022-12-20 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem |
| 2022-12-16 | Injury | None | Device Damaged by Another Device, Device Dislodged or Dislocated |
| 2022-12-14 | Injury | None | Device Dislodged or Dislocated |
| 2022-12-13 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2022-12-09 | Injury | Non specific EKG/ECG Changes | None |
| 2022-12-09 | Death | None | Activation Failure, Patient Device Interaction Problem |
| 2022-12-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-12-08 | Injury | None | Gradient Increase, Device Dislodged or Dislocated |
| 2022-12-07 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-12-06 | Injury | None | Device Dislodged or Dislocated, Activation Failure |
| 2022-12-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-30 | Injury | None | Perivalvular Leak, Device Dislodged or Dislocated |
| 2022-11-28 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-11-22 | Injury | None | Gradient Increase, Device Dislodged or Dislocated |
| 2022-11-22 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2022-11-21 | Injury | None | Perivalvular Leak, Device Dislodged or Dislocated |
| 2022-11-21 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-11-21 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-11-17 | Injury | None | Perivalvular Leak, Malposition of Device, Device Dislodged or Dislocated |
| 2022-11-16 | Injury | None | Device Dislodged or Dislocated |
| 2022-11-15 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem |
| 2022-11-14 | Injury | Non specific EKG/ECG Changes | None |
| 2022-11-11 | Injury | None | Perivalvular Leak, Device Dislodged or Dislocated |
| 2022-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-07 | Injury | Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2022-11-02 | Injury | None | Device Dislodged or Dislocated |
| 2022-11-01 | Injury | None | Perivalvular Leak, Device Dislodged or Dislocated |
| 2022-10-26 | Injury | None | Device Dislodged or Dislocated, Patient Device Interaction Problem |
| 2022-10-26 | Injury | None | Device Dislodged or Dislocated |
| 2022-10-26 | Injury | None | Perivalvular Leak, Failure to Advance, Device Dislodged or Dislocated, Activation Failure |
| 2022-10-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-25 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-18 | Injury | None | Perivalvular Leak, Device Dislodged or Dislocated |
| 2022-10-07 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2022-10-07 | Injury | None | Device Dislodged or Dislocated |
| 2022-10-06 | Injury | None | Device Dislodged or Dislocated |
| 2022-10-05 | Injury | None | Device Dislodged or Dislocated, Activation Problem |
| 2022-09-22 | Injury | None | Perivalvular Leak |
| 2022-09-20 | Injury | None | Malposition of Device, Device Dislodged or Dislocated |
| 2022-09-19 | Injury | Non specific EKG/ECG Changes | Patient Device Interaction Problem |
| 2022-09-12 | Death | None | Device Dislodged or Dislocated |
| 2022-09-06 | Injury | None | Device Dislodged or Dislocated |
| 2022-08-30 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem |
| 2022-08-26 | Injury | None | Activation Failure |
| 2022-08-25 | Injury | None | Gradient Increase, Device Dislodged or Dislocated, Activation Failure |
| 2022-08-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-02 | Injury | None | Insufficient Information |
| 2022-03-02 | Injury | None | Insufficient Information |
| 2022-03-02 | Injury | None | Insufficient Information |