AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
This device is manufactured by EDWARDS LIFESCIENCES.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-31 | Injury | Rupture | None |
| 2024-07-29 | Injury | Thrombosis/Thrombus | None |
| 2024-07-09 | Injury | Insufficient Information | None |
| 2024-07-09 | Injury | Foreign Body Embolism | None |
| 2024-07-08 | Injury | Foreign Body In Patient | None |
| 2024-07-05 | Injury | Insufficient Information | None |
| 2024-07-05 | Injury | Insufficient Information | None |
| 2024-07-04 | Injury | Ischemia Stroke, Foreign Body Embolism | None |
| 2024-07-03 | Injury | Dyspnea | None |
| 2024-07-01 | Injury | Insufficient Information | None |
| 2024-07-01 | Injury | Insufficient Information | Calcified |
| 2024-07-01 | Injury | Heart Failure/Congestive Heart Failure | Calcified, Perivalvular Leak |
| 2024-07-01 | Injury | Insufficient Information | None |
| 2024-06-28 | Injury | Foreign Body In Patient | None |
| 2024-06-27 | Injury | Foreign Body In Patient | None |
| 2024-06-27 | Death | Rupture | None |
| 2024-06-26 | Injury | Insufficient Information | Perivalvular Leak, Malposition of Device, Migration |
| 2024-06-25 | Injury | Rupture | None |
| 2024-06-25 | Injury | Insufficient Information | Migration or Expulsion of Device |
| 2024-06-25 | Injury | Insufficient Information | None |
| 2024-06-20 | Injury | Atrial Fibrillation, Stroke/CVA | None |
| 2024-06-17 | Injury | Insufficient Information | None |
| 2024-06-14 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2024-06-14 | Injury | Dyspnea | None |
| 2024-06-13 | Injury | Dizziness, Insufficient Information | Calcified, Difficult to Open or Close |
| 2024-06-11 | Injury | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2024-06-07 | Injury | Dyspnea, Fatigue, Dizziness | Degraded |
| 2024-06-06 | Injury | Unspecified Vascular Problem | Material Deformation |
| 2024-06-05 | Injury | Insufficient Information | Insufficient Information, Device Stenosis, Central Regurgitation |
| 2024-06-05 | Death | Unspecified Heart Problem | Insufficient Information |
| 2024-06-05 | Death | Unspecified Heart Problem | Insufficient Information |
| 2024-06-05 | Death | Insufficient Information | Insufficient Information |
| 2024-06-05 | Injury | Insufficient Information | None |
| 2024-06-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2024-06-03 | Injury | Insufficient Information | None |
| 2024-05-31 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2024-05-30 | Injury | Dyspnea, Insufficient Information | Insufficient Information |
| 2024-05-30 | Injury | Insufficient Information | Degraded, Fluid/Blood Leak |
| 2024-05-29 | Injury | Insufficient Information | Patient Device Interaction Problem |
| 2024-05-29 | Injury | Insufficient Information | Malposition of Device |
| 2024-05-29 | Injury | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2024-05-28 | Injury | Insufficient Information | Insufficient Information |
| 2024-05-28 | Injury | No Clinical Signs, Symptoms or Conditions | Perivalvular Leak, Malposition of Device |
| 2024-05-28 | Injury | Low Blood Pressure/ Hypotension | Migration or Expulsion of Device |
| 2024-05-28 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2024-05-27 | Death | Bradycardia, Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2024-05-27 | Injury | Hemolysis | Perivalvular Leak, Material Deformation |
| 2024-05-24 | Injury | Insufficient Information | Insufficient Information |
| 2024-05-24 | Injury | Foreign Body In Patient | Adverse Event Without Identified Device or Use Problem |
| 2024-05-22 | Injury | Insufficient Information | Insufficient Information |
| 2024-05-21 | Injury | Foreign Body Embolism | Migration or Expulsion of Device |
| 2024-05-21 | Injury | Heart Failure/Congestive Heart Failure, Insufficient Information | Insufficient Information, Device Stenosis |
| 2024-05-17 | Injury | Dyspnea | Calcified |
| 2024-05-16 | Injury | Heart Failure/Congestive Heart Failure | Device Stenosis |
| 2024-05-16 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2024-05-16 | Injury | Insufficient Information | Malposition of Device |
| 2024-05-16 | Injury | Insufficient Information | None |
| 2024-05-15 | Injury | Heart Failure/Congestive Heart Failure | Perivalvular Leak, Device Stenosis |
| 2024-05-14 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2024-05-09 | Injury | Dyspnea, Insufficient Information | Calcified, Device Stenosis |
| 2024-05-03 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2024-05-03 | Injury | Heart Failure/Congestive Heart Failure | Fluid/Blood Leak, Central Regurgitation |
| 2024-05-02 | Injury | Insufficient Information | Insufficient Information |
| 2024-05-02 | Injury | Fistula, Hemolysis | Gradient Increase, Perivalvular Leak |
| 2024-05-01 | Injury | Insufficient Information | Difficult to Open or Close, Central Regurgitation |
| 2024-04-30 | Injury | Hemolytic Anemia | Perivalvular Leak |
| 2024-04-30 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2024-04-30 | Injury | Insufficient Information | Calcified, Gradient Increase |
| 2024-04-29 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-04-29 | Injury | Heart Failure/Congestive Heart Failure | Device Stenosis |
| 2024-04-26 | Injury | Hemolysis | Fluid/Blood Leak |
| 2024-04-25 | Injury | Foreign Body In Patient | Adverse Event Without Identified Device or Use Problem |
| 2024-04-24 | Injury | Heart Failure/Congestive Heart Failure, Insufficient Information | Perivalvular Leak, Insufficient Information |
| 2024-04-24 | Injury | Aortic Valve Insufficiency/ Regurgitation | Perivalvular Leak |
| 2024-04-23 | Injury | Dyspnea | Calcified |
| 2024-04-23 | Injury | Insufficient Information | Central Regurgitation |
| 2024-04-22 | Injury | Insufficient Information | Device Stenosis |
| 2024-04-22 | Injury | Insufficient Information | Fluid/Blood Leak, Difficult to Open or Close |
| 2024-04-22 | Injury | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2024-04-22 | Injury | Insufficient Information | Insufficient Information |
| 2024-04-19 | Death | Great Vessel Perforation, Foreign Body In Patient | Migration or Expulsion of Device, Malposition of Device |
| 2024-04-18 | Injury | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2024-04-18 | Injury | Insufficient Information | Degraded |
| 2024-04-15 | Injury | Foreign Body In Patient, Unspecified Vascular Problem | None |
| 2024-04-14 | Injury | Insufficient Information | Fluid/Blood Leak, Perivalvular Leak, Device Stenosis |
| 2024-04-12 | Injury | Insufficient Information | Device Stenosis, Central Regurgitation |
| 2024-04-11 | Injury | No Clinical Signs, Symptoms or Conditions | Perivalvular Leak, Malposition of Device, Central Regurgitation |
| 2024-04-11 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2024-04-10 | Injury | Insufficient Information | Device Stenosis |
| 2024-04-10 | Injury | Insufficient Information | Central Regurgitation |
| 2024-04-09 | Death | Insufficient Information | Malposition of Device, Migration |
| 2024-04-08 | Injury | Dyspnea | Calcified, Device Stenosis |
| 2024-04-05 | Injury | Endocarditis, Insufficient Information | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2024-04-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Contaminated During Manufacture or Shipping |
| 2024-04-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-03 | Injury | No Clinical Signs, Symptoms or Conditions | Perivalvular Leak, Malposition of Device |
| 2024-04-03 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2024-04-02 | Malfunction | Insufficient Information | Material Twisted/Bent |
| 2024-04-02 | Injury | Insufficient Information | Insufficient Information, Device Stenosis |
| 2024-03-29 | Injury | Insufficient Information | None |
| 2024-03-28 | Injury | Insufficient Information | Perivalvular Leak, Central Regurgitation |
| 2024-03-28 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2024-03-27 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-03-26 | Injury | Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2024-03-26 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2024-03-25 | Injury | Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2024-03-21 | Injury | Insufficient Information | None |
| 2024-03-20 | Injury | Heart Block | None |
| 2024-03-20 | Injury | Insufficient Information | Insufficient Information |
| 2024-03-19 | Injury | Dyspnea, Heart Failure/Congestive Heart Failure | Calcified, Patient Device Interaction Problem |
| 2024-03-18 | Injury | Foreign Body In Patient | Adverse Event Without Identified Device or Use Problem |
| 2024-03-13 | Injury | Insufficient Information | None |
| 2024-03-12 | Injury | Insufficient Information | None |
| 2024-03-08 | Injury | Stroke/CVA | None |
| 2024-03-07 | Injury | Insufficient Information | Insufficient Information |
| 2024-03-06 | Injury | Foreign Body In Patient | None |
| 2024-03-06 | Injury | Insufficient Information | None |
| 2024-03-04 | Injury | Insufficient Information | None |
| 2024-03-04 | Injury | Hemolysis | None |
| 2024-03-04 | Injury | Vascular Dissection | None |
| 2024-03-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Nonstandard Device |
| 2024-03-04 | Injury | Dyspnea, Insufficient Information | None |
| 2024-02-29 | Injury | Endocarditis, Insufficient Information | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2024-02-28 | Injury | Insufficient Information | None |
| 2024-02-28 | Injury | Rupture | None |
| 2024-02-25 | Injury | Insufficient Information | None |
| 2024-02-21 | Injury | Dyspnea | None |
| 2024-02-21 | Injury | Insufficient Information | None |
| 2024-02-20 | Injury | Rupture | None |
| 2024-02-19 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-02-16 | Injury | Insufficient Information | None |
| 2024-02-16 | Injury | Dyspnea, Fatigue, Peripheral Edema | Central Regurgitation |
| 2024-02-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Twisted/Bent |
| 2024-02-14 | Injury | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2024-02-13 | Injury | Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2024-02-13 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2024-02-13 | Injury | Insufficient Information | Insufficient Information |
| 2024-02-12 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-02-12 | Injury | Insufficient Information | None |
| 2024-02-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2024-02-12 | Injury | Insufficient Information | Insufficient Information |
| 2024-02-12 | Injury | Rupture, Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2024-02-10 | Death | Appropriate Term / Code Not Available | Malposition of Device |
| 2024-02-09 | Injury | No Clinical Signs, Symptoms or Conditions | Perivalvular Leak, Malposition of Device |
| 2024-02-09 | Injury | Insufficient Information | Degraded, Gradient Increase |
| 2024-02-09 | Injury | Dizziness | Calcified, Perivalvular Leak |
| 2024-02-09 | Injury | Insufficient Information | Insufficient Information |
| 2024-02-08 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2024-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2024-02-07 | Death | Rupture, Cardiogenic Shock | Fluid/Blood Leak, Adverse Event Without Identified Device or Use Problem |
| 2024-02-07 | Injury | No Clinical Signs, Symptoms or Conditions | Calcified, Fluid/Blood Leak |
| 2024-02-07 | Injury | Foreign Body In Patient | Material Deformation |
| 2024-02-07 | Injury | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Malposition of Device |
| 2024-02-06 | Injury | Insufficient Information | Perivalvular Leak, Malposition of Device |
| 2024-02-05 | Injury | Dyspnea | Perivalvular Leak |
| 2024-02-02 | Injury | No Clinical Signs, Symptoms or Conditions | Gradient Increase |
| 2024-02-02 | Injury | Dyspnea | None |
| 2024-02-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2024-01-31 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-01-31 | Injury | Insufficient Information | Calcified, Gradient Increase |
| 2024-01-31 | Injury | Dyspnea, Hemolytic Anemia | Fluid/Blood Leak, Fracture, Perivalvular Leak |
| 2024-01-30 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2024-01-30 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2024-01-30 | Injury | Insufficient Information | Perivalvular Leak |
| 2024-01-29 | Injury | Insufficient Information | Insufficient Information |
| 2024-01-26 | Injury | Insufficient Information | Degraded |
| 2024-01-25 | Injury | Dyspnea, Hemolysis | Calcified |
| 2024-01-24 | Injury | Heart Failure/Congestive Heart Failure | Central Regurgitation |
| 2024-01-23 | Injury | Foreign Body Embolism | Migration or Expulsion of Device |
| 2024-01-22 | Injury | Dyspnea | Gradient Increase |
| 2024-01-22 | Injury | Insufficient Information, No Clinical Signs, Symptoms or Conditions | None |
| 2024-01-22 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2024-01-22 | Injury | Dyspnea | Migration or Expulsion of Device, Perivalvular Leak, Malposition of Device |
| 2024-01-21 | Injury | Insufficient Information | Insufficient Information |
| 2024-01-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2024-01-17 | Injury | Insufficient Information | Insufficient Information |
| 2024-01-17 | Injury | Insufficient Information | Insufficient Information |
| 2024-01-16 | Injury | Insufficient Information | Insufficient Information |
| 2024-01-10 | Injury | Dyspnea, Insufficient Information | Gradient Increase, Insufficient Information |
| 2024-01-05 | Injury | No Clinical Signs, Symptoms or Conditions | Perivalvular Leak, Malposition of Device |
| 2024-01-04 | Injury | Dyspnea, Dizziness, Insufficient Information | Insufficient Information, Device Stenosis |
| 2024-01-04 | Injury | Dyspnea | Central Regurgitation |
| 2024-01-03 | Injury | Insufficient Information | Perivalvular Leak, Malposition of Device |
| 2024-01-03 | Injury | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2023-12-26 | Injury | Dyspnea | Gradient Increase |
| 2023-12-21 | Injury | Hematoma, Pleural Effusion, Tachycardia, Rupture | Adverse Event Without Identified Device or Use Problem |
| 2023-12-21 | Injury | Insufficient Information | Insufficient Information |
| 2023-12-15 | Injury | Heart Failure/Congestive Heart Failure | Degraded, Incomplete Coaptation, Difficult to Open or Close, Central Regurgitation |
| 2023-12-14 | Injury | Vascular Dissection | Malposition of Device |
| 2023-12-13 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-12-12 | Injury | Obstruction/Occlusion | Insufficient Information |
| 2023-12-12 | Injury | Insufficient Information | None |
| 2023-12-12 | Malfunction | Insufficient Information | None |
| 2023-12-12 | Injury | Heart Block | None |
| 2023-12-11 | Injury | Insufficient Information | None |
| 2023-12-11 | Injury | Insufficient Information | Device Stenosis |
| 2023-12-11 | Injury | Insufficient Information | None |
| 2023-12-05 | Injury | Heart Block | None |
| 2023-12-05 | Injury | Insufficient Information | Insufficient Information |
| 2023-12-04 | Injury | Thrombosis/Thrombus, Heart Failure/Congestive Heart Failure, Insufficient Information | Calcified, Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2023-12-04 | Injury | Dyspnea, Insufficient Information | Device Stenosis, Central Regurgitation |
| 2023-12-04 | Injury | Endocarditis, Insufficient Information | None |
| 2023-12-01 | Injury | Heart Failure/Congestive Heart Failure | Perivalvular Leak, Device Stenosis |
| 2023-12-01 | Injury | Hemolysis | None |
| 2023-12-01 | Injury | Thrombosis/Thrombus, Insufficient Information | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2023-11-30 | Injury | Hemolysis, Insufficient Information | Perivalvular Leak, Insufficient Information |
| 2023-11-28 | Injury | Insufficient Information | Insufficient Information |
| 2023-11-22 | Injury | Insufficient Information | Insufficient Information |
| 2023-11-21 | Injury | Dyspnea, Insufficient Information | None |
| 2023-11-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Nonstandard Device |
| 2023-11-14 | Injury | Insufficient Information | Insufficient Information |
| 2023-11-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-11-14 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-11-12 | Death | Unspecified Heart Problem | Insufficient Information |
| 2023-11-10 | Injury | Insufficient Information | Insufficient Information |
| 2023-11-09 | Injury | Dyspnea, Insufficient Information | Adverse Event Without Identified Device or Use Problem, Central Regurgitation |
| 2023-11-06 | Injury | Insufficient Information | Migration, Central Regurgitation |
| 2023-11-02 | Injury | Vascular Dissection | Material Deformation |
| 2023-10-31 | Injury | Insufficient Information | Device Stenosis |
| 2023-10-31 | Injury | Insufficient Information | Migration or Expulsion of Device |
| 2023-10-29 | Injury | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2023-10-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-10-25 | Injury | Insufficient Information | Material Split, Cut or Torn |
| 2023-10-25 | Injury | Hematoma, Hemorrhage/Blood Loss/Bleeding, Vascular Dissection | Material Deformation |
| 2023-10-24 | Injury | Insufficient Information | None |
| 2023-10-24 | Injury | Obstruction/Occlusion, No Clinical Signs, Symptoms or Conditions | Perivalvular Leak, Adverse Event Without Identified Device or Use Problem |
| 2023-10-23 | Injury | Insufficient Information | Perivalvular Leak |
| 2023-10-20 | Injury | Heart Block | None |
| 2023-10-19 | Death | Vascular Dissection | Material Deformation |
| 2023-10-19 | Injury | Heart Failure/Congestive Heart Failure | Degraded |
| 2023-10-19 | Injury | No Clinical Signs, Symptoms or Conditions | Perivalvular Leak, Malposition of Device |
| 2023-10-19 | Injury | Hemolytic Anemia, Insufficient Information | Fluid/Blood Leak, Perivalvular Leak |
| 2023-10-18 | Injury | Insufficient Information | Malposition of Device |
| 2023-10-18 | Injury | Insufficient Information | Migration or Expulsion of Device |
| 2023-10-17 | Injury | Vascular Dissection | None |
| 2023-10-17 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-10-17 | Death | Cardiac Arrest, Myocardial Infarction, Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2023-10-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-10-13 | Injury | Hemolysis, Renal Failure, Hematuria | Fluid/Blood Leak |
| 2023-10-12 | Injury | Dyspnea, Insufficient Information | Calcified, Adverse Event Without Identified Device or Use Problem |
| 2023-10-12 | Injury | Heart Failure/Congestive Heart Failure | Fluid/Blood Leak |
| 2023-10-09 | Injury | Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2023-10-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-10-05 | Injury | Insufficient Information | Fluid/Blood Leak, Gradient Increase |
| 2023-10-05 | Injury | No Clinical Signs, Symptoms or Conditions | Perivalvular Leak |
| 2023-10-05 | Injury | Endocarditis, Insufficient Information | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2023-10-04 | Injury | No Clinical Signs, Symptoms or Conditions | Malposition of Device |
| 2023-10-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Contamination with Chemical or Other Material |
| 2023-10-03 | Injury | No Clinical Signs, Symptoms or Conditions | Malposition of Device |
| 2023-09-29 | Injury | Valvular Insufficiency/ Regurgitation, No Clinical Signs, Symptoms or Conditions | Malposition of Device, Unintended Movement, Central Regurgitation |
| 2023-09-28 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-09-28 | Injury | Insufficient Information | Insufficient Information |
| 2023-09-27 | Injury | Foreign Body In Patient | Malposition of Device |
| 2023-09-27 | Injury | Insufficient Information | Fluid/Blood Leak, Gradient Increase |
| 2023-09-26 | Injury | Insufficient Information | Unintended Collision |
| 2023-09-26 | Injury | No Clinical Signs, Symptoms or Conditions | Fluid/Blood Leak, Malposition of Device |
| 2023-09-25 | Injury | Foreign Body In Patient, Vascular Dissection | Malposition of Device |
| 2023-09-25 | Injury | Insufficient Information | Insufficient Information |
| 2023-09-21 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2023-09-21 | Injury | Swelling/ Edema | Central Regurgitation |
| 2023-09-20 | Injury | Insufficient Information | Perivalvular Leak |
| 2023-09-20 | Injury | Aortic Valve Insufficiency/ Regurgitation | Perivalvular Leak |
| 2023-09-20 | Death | Cardiac Arrest, Ventricular Fibrillation, Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-19 | Injury | Dyspnea, Insufficient Information | Fluid/Blood Leak, Device Stenosis, Central Regurgitation |
| 2023-09-19 | Injury | Insufficient Information | Perivalvular Leak, Malposition of Device |
| 2023-09-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Contaminated During Manufacture or Shipping |
| 2023-09-18 | Injury | Insufficient Information | Perivalvular Leak |
| 2023-09-15 | Injury | Dyspnea | Perivalvular Leak |
| 2023-09-13 | Injury | Insufficient Information | Insufficient Information |
| 2023-09-13 | Injury | Aortic Valve Stenosis, Dyspnea | Degraded |
| 2023-09-13 | Injury | Insufficient Information | Migration or Expulsion of Device |
| 2023-09-11 | Injury | Insufficient Information | None |
| 2023-09-11 | Injury | Dyspnea | Device Stenosis |
| 2023-09-02 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-08-30 | Injury | Foreign Body Embolism | Migration or Expulsion of Device |
| 2023-08-25 | Injury | Foreign Body In Patient, Embolism/Embolus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-24 | Malfunction | Insufficient Information | Material Deformation |
| 2023-08-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Twisted/Bent |
| 2023-08-23 | Injury | Dyspnea | Degraded, Device Stenosis |
| 2023-08-22 | Injury | Insufficient Information | Malposition of Device, Insufficient Information, Central Regurgitation |
| 2023-08-22 | Injury | Thrombosis/Thrombus, Insufficient Information | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2023-08-22 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2023-08-22 | Injury | Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2023-08-22 | Injury | Insufficient Information | Perivalvular Leak |
| 2023-08-21 | Injury | Insufficient Information | Calcified, Perivalvular Leak |
| 2023-08-10 | Injury | Endocarditis, Insufficient Information | Insufficient Information |
| 2023-08-08 | Injury | Fatigue, Hemolysis | Fluid/Blood Leak |
| 2023-08-08 | Death | Rupture | Material Deformation |
| 2023-08-08 | Death | Myocardial Infarction, Rupture, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-08-08 | Injury | Low Blood Pressure/ Hypotension | Fluid/Blood Leak, Difficult to Open or Close |
| 2023-08-04 | Injury | Endocarditis, Insufficient Information | Insufficient Information |
| 2023-08-04 | Injury | No Clinical Signs, Symptoms or Conditions | Malposition of Device |
| 2023-08-03 | Death | Cardiac Arrest, Rupture | Adverse Event Without Identified Device or Use Problem |
| 2023-08-02 | Injury | Dyspnea | Patient Device Interaction Problem |
| 2023-08-02 | Injury | Heart Failure/Congestive Heart Failure | Central Regurgitation |
| 2023-08-02 | Injury | Dyspnea | None |
| 2023-07-31 | Injury | Insufficient Information | Insufficient Information |
| 2023-07-28 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-07-27 | Death | Myocardial Infarction | None |
| 2023-07-27 | Injury | Dyspnea | Calcified |
| 2023-07-27 | Injury | Foreign Body In Patient, Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-26 | Injury | No Clinical Signs, Symptoms or Conditions | Migration or Expulsion of Device |
| 2023-07-25 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2023-07-24 | Injury | Insufficient Information | Perivalvular Leak |
| 2023-07-24 | Injury | Fatigue, No Clinical Signs, Symptoms or Conditions | Calcified, Device Stenosis, Central Regurgitation |
| 2023-07-24 | Injury | Heart Failure/Congestive Heart Failure, Insufficient Information | Calcified, Device Stenosis |
| 2023-07-24 | Death | Dyspnea, No Clinical Signs, Symptoms or Conditions | Restricted Flow rate, Fluid/Blood Leak, Insufficient Information, Device Stenosis |
| 2023-07-21 | Injury | Insufficient Information | Device Stenosis |
| 2023-07-20 | Injury | Insufficient Information | Fluid/Blood Leak |
| 2023-07-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Contaminated During Manufacture or Shipping |
| 2023-07-17 | Injury | Insufficient Information | Perivalvular Leak |
| 2023-07-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Product Quality Problem, Difficult to Open or Close |
| 2023-07-17 | Injury | Insufficient Information | Migration |
| 2023-07-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-07-14 | Death | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2023-07-14 | Injury | Insufficient Information | Insufficient Information |
| 2023-07-12 | Injury | Foreign Body In Patient | Malposition of Device |
| 2023-07-10 | Death | Stroke/CVA, Endocarditis | Adverse Event Without Identified Device or Use Problem |
| 2023-07-07 | Injury | No Clinical Signs, Symptoms or Conditions | Perivalvular Leak |
| 2023-07-07 | Injury | Insufficient Information | Insufficient Information |
| 2023-07-06 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2023-07-06 | Injury | No Clinical Signs, Symptoms or Conditions | Degraded |
| 2023-07-05 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-07-05 | Injury | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2023-07-05 | Injury | Aortic Valve Insufficiency/ Regurgitation | Degraded, Perivalvular Leak |
| 2023-07-05 | Injury | Insufficient Information | Insufficient Information |
| 2023-07-01 | Death | Appropriate Term / Code Not Available | Insufficient Information |
| 2023-07-01 | Death | Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2023-07-01 | Death | Aortic Valve Insufficiency/ Regurgitation | Insufficient Information |
| 2023-07-01 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2023-07-01 | Death | Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-07-01 | Death | Ischemia Stroke | Adverse Event Without Identified Device or Use Problem |
| 2023-07-01 | Death | Mitral Valve Insufficiency/ Regurgitation | Insufficient Information |
| 2023-07-01 | Death | Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2023-07-01 | Death | Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-07-01 | Death | Appropriate Term / Code Not Available | Insufficient Information |
| 2023-07-01 | Death | Appropriate Term / Code Not Available | Insufficient Information |
| 2023-07-01 | Death | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-07-01 | Death | Appropriate Term / Code Not Available | Adverse Event Without Identified Device or Use Problem |
| 2023-07-01 | Death | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-28 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-06-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-06-24 | Injury | Dyspnea, Insufficient Information | Calcified, Insufficient Information, Device Stenosis |
| 2023-06-23 | Injury | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2023-06-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Split, Cut or Torn |
| 2023-06-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Nonstandard Device |
| 2023-06-19 | Death | Insufficient Information | Migration or Expulsion of Device, Malposition of Device, Migration, Central Regurgitation |
| 2023-06-16 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-06-15 | Injury | Insufficient Information | Insufficient Information |
| 2023-06-14 | Injury | Insufficient Information | Difficult to Open or Close |
| 2023-06-12 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-06-12 | Injury | Insufficient Information | Fluid/Blood Leak, Gradient Increase |
| 2023-06-08 | Injury | Foreign Body In Patient | Adverse Event Without Identified Device or Use Problem |
| 2023-06-07 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2023-06-07 | Injury | Insufficient Information | Device Stenosis |
| 2023-06-06 | Injury | Endocarditis, Insufficient Information | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2023-06-06 | Injury | Pulmonary Valve Stenosis, Thrombosis/Thrombus | Degraded, Difficult to Open or Close, Patient Device Interaction Problem |
| 2023-06-06 | Injury | Insufficient Information | Perivalvular Leak, Difficult to Open or Close, Adverse Event Without Identified Device or Use Problem |
| 2023-06-05 | Malfunction | Insufficient Information | Material Deformation |
| 2023-06-02 | Injury | Insufficient Information | Insufficient Information |
| 2023-06-02 | Injury | Dyspnea, Fatigue, Insufficient Information | Degraded, Fluid/Blood Leak, Difficult to Open or Close, Insufficient Information, Device Stenosis, Central Regurgitation |
| 2023-05-30 | Death | Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2023-05-25 | Injury | Insufficient Information | Gradient Increase, Insufficient Information, Device Stenosis |
| 2023-05-24 | Injury | Insufficient Information | Perivalvular Leak |
| 2023-05-23 | Injury | Insufficient Information | Insufficient Information |
| 2023-05-23 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-05-17 | Injury | Anemia | Perivalvular Leak |
| 2023-05-14 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-05-12 | Injury | Dyspnea | Fluid/Blood Leak |
| 2023-05-10 | Death | Hemolysis | Perivalvular Leak |
| 2023-05-10 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-05-04 | Injury | Foreign Body In Patient | Device Dislodged or Dislocated |
| 2023-05-04 | Injury | Insufficient Information | Perivalvular Leak, Device Stenosis |
| 2023-05-04 | Injury | Foreign Body Embolism | Migration or Expulsion of Device |
| 2023-05-03 | Injury | Insufficient Information | Gradient Increase |
| 2023-04-30 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-04-28 | Injury | Insufficient Information | Insufficient Information |
| 2023-04-26 | Malfunction | Insufficient Information | Improper or Incorrect Procedure or Method, Defective Device, Material Twisted/Bent |
| 2023-04-26 | Injury | Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2023-04-25 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-04-25 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-04-24 | Injury | Hemolytic Anemia, Insufficient Information | Degraded, Gradient Increase, Insufficient Information, Patient Device Interaction Problem |
| 2023-04-24 | Injury | Endocarditis, Insufficient Information | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2023-04-06 | Injury | Heart Failure/Congestive Heart Failure, Insufficient Information | Perivalvular Leak |
| 2023-03-29 | Injury | Insufficient Information | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2023-03-28 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2023-03-23 | Injury | Endocarditis, Insufficient Information | Insufficient Information |
| 2023-03-21 | Injury | Dyspnea | Patient-Device Incompatibility |
| 2023-03-17 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-03-14 | Injury | Insufficient Information | None |
| 2023-03-10 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2023-03-09 | Injury | Insufficient Information | Perivalvular Leak |
| 2023-03-09 | Injury | Insufficient Information | Perivalvular Leak, Malposition of Device |
| 2023-03-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-03-08 | Injury | Stroke/CVA, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-03-08 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-03-07 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2023-03-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Deformation |
| 2023-03-03 | Death | Stroke/CVA, Foreign Body In Patient | Adverse Event Without Identified Device or Use Problem |
| 2023-03-01 | Injury | Endocarditis | Adverse Event Without Identified Device or Use Problem |
| 2023-03-01 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2023-02-24 | Injury | Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2023-02-23 | Injury | Hemolysis | Fluid/Blood Leak, Perivalvular Leak, Material Split, Cut or Torn |
| 2023-02-23 | Injury | Foreign Body In Patient | Migration or Expulsion of Device, Malposition of Device |
| 2023-02-22 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-02-22 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-02-22 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2023-02-20 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2023-02-18 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-02-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Malposition of Device, Misassembly by Users |
| 2023-02-15 | Death | Aortic Valve Insufficiency/ Regurgitation | Fluid/Blood Leak |
| 2023-02-13 | Injury | Insufficient Information | Perivalvular Leak, Malposition of Device |
| 2023-02-13 | Injury | Heart Block | Material Deformation, Adverse Event Without Identified Device or Use Problem |
| 2023-02-10 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-02-09 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-02-09 | Injury | Unspecified Vascular Problem | Adverse Event Without Identified Device or Use Problem |
| 2023-02-07 | Injury | Pericardial Effusion, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-01-30 | Injury | Heart Failure/Congestive Heart Failure | Calcified |
| 2023-01-30 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-01-26 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-01-23 | Injury | Foreign Body In Patient | Migration or Expulsion of Device |
| 2023-01-18 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-01-17 | Injury | Insufficient Information | Fluid/Blood Leak, Migration or Expulsion of Device |
| 2023-01-17 | Death | Rupture | Adverse Event Without Identified Device or Use Problem |
| 2023-01-17 | Injury | Insufficient Information | Fluid/Blood Leak, Gradient Increase |
| 2023-01-12 | Injury | Insufficient Information | Degraded |
| 2023-01-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Device Contamination with Chemical or Other Material, Insufficient Information |
| 2023-01-09 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2023-01-09 | Death | Obstruction/Occlusion | Gradient Increase, Adverse Event Without Identified Device or Use Problem |
| 2023-01-04 | Injury | Insufficient Information | Migration or Expulsion of Device |
| 2023-01-04 | Injury | Hemolysis, Insufficient Information | Fluid/Blood Leak, Perivalvular Leak |
| 2023-01-03 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-12-29 | Injury | Insufficient Information | Fluid/Blood Leak |
| 2022-12-21 | Death | Perforation of Vessels | Material Deformation |
| 2022-12-16 | Injury | Dyspnea, Insufficient Information | Calcified, Gradient Increase, Insufficient Information |
| 2022-12-16 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-12-13 | Injury | Insufficient Information | Fluid/Blood Leak |
| 2022-12-12 | Injury | Insufficient Information | Calcified, Adverse Event Without Identified Device or Use Problem |
| 2022-12-12 | Injury | None | Structural Problem |
| 2022-12-12 | Injury | Insufficient Information | Insufficient Information |
| 2022-12-08 | Injury | Heart Failure/Congestive Heart Failure | Fluid/Blood Leak, Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2022-11-30 | Injury | None | Fluid/Blood Leak |
| 2022-11-30 | Malfunction | None | Material Deformation |
| 2022-11-29 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-24 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-11-24 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-11-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-10 | Injury | None | Perivalvular Leak, Malposition of Device |
| 2022-11-09 | Injury | None | Fluid/Blood Leak, Gradient Increase, Difficult to Open or Close |
| 2022-11-08 | Injury | Endocarditis, Insufficient Information | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2022-11-07 | Injury | None | Gradient Increase |
| 2022-11-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-02 | Injury | None | Insufficient Information |
| 2022-11-01 | Injury | None | Fluid/Blood Leak, Perivalvular Leak, Malposition of Device |
| 2022-10-31 | Injury | None | Malposition of Device |
| 2022-10-30 | Death | Cardiac Arrest, Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2022-10-28 | Injury | None | Perivalvular Leak, Malposition of Device |
| 2022-10-28 | Injury | None | Migration or Expulsion of Device |
| 2022-10-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-26 | Injury | None | Migration or Expulsion of Device, Malposition of Device |
| 2022-10-26 | Injury | None | Fluid/Blood Leak |
| 2022-10-26 | Injury | None | Perivalvular Leak |
| 2022-10-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-20 | Injury | None | Migration or Expulsion of Device |
| 2022-10-17 | Injury | None | Perivalvular Leak |
| 2022-10-12 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-12 | Injury | Insufficient Information | Malposition of Device |
| 2022-10-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-07 | Injury | None | Migration or Expulsion of Device, Perivalvular Leak, Malposition of Device |
| 2022-10-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-04 | Injury | None | Migration or Expulsion of Device |
| 2022-10-03 | Injury | None | Insufficient Information |
| 2022-09-30 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-09-28 | Injury | None | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2022-09-26 | Injury | None | Malposition of Device |
| 2022-09-26 | Injury | None | Fluid/Blood Leak, Difficult to Open or Close |
| 2022-09-21 | Injury | None | Device Damaged by Another Device |
| 2022-09-21 | Malfunction | None | Material Deformation |
| 2022-09-21 | Injury | Arrhythmia | Adverse Event Without Identified Device or Use Problem |
| 2022-09-20 | Malfunction | None | Defective Device |
| 2022-09-19 | Malfunction | None | Material Deformation |
| 2022-09-16 | Injury | None | Insufficient Information |
| 2022-09-15 | Injury | None | Degraded, Perivalvular Leak |
| 2022-09-15 | Injury | Bradycardia | Adverse Event Without Identified Device or Use Problem |
| 2022-09-13 | Death | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2022-09-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-09 | Injury | None | Insufficient Information |
| 2022-09-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-07 | Malfunction | None | Device Difficult to Setup or Prepare |
| 2022-09-07 | Injury | None | Malposition of Device |
| 2022-09-02 | Injury | None | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2022-09-01 | Malfunction | None | Material Deformation |
| 2022-08-31 | Injury | None | Insufficient Information |
| 2022-08-30 | Injury | None | Fluid/Blood Leak, Perivalvular Leak |
| 2022-08-23 | Injury | None | Insufficient Information |
| 2022-08-23 | Injury | None | Insufficient Information |
| 2022-08-15 | Injury | None | Calcified |
| 2022-08-14 | Injury | None | Insufficient Information |
| 2022-08-12 | Injury | None | Insufficient Information |
| 2022-08-09 | Injury | None | Perivalvular Leak, Adverse Event Without Identified Device or Use Problem |
| 2022-08-09 | Malfunction | None | Material Deformation |
| 2022-08-05 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-08-04 | Injury | None | Insufficient Information |
| 2022-08-03 | Injury | None | Material Deformation |
| 2022-08-02 | Injury | None | Insufficient Information |
| 2022-07-31 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-17 | Death | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2022-07-15 | Injury | None | Insufficient Information |
| 2022-07-15 | Injury | None | Insufficient Information |
| 2022-07-15 | Injury | None | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2022-07-13 | Malfunction | None | Material Deformation |
| 2022-07-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-07 | Injury | None | Perivalvular Leak |
| 2022-06-20 | Injury | None | Insufficient Information |
| 2022-06-02 | Injury | None | Fluid/Blood Leak, Perivalvular Leak |
| 2022-05-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-05-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-05-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-05-12 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-05-01 | Injury | Appropriate Term / Code Not Available | Device Dislodged or Dislocated |
| 2022-04-29 | Injury | None | Insufficient Information |
| 2022-04-25 | Injury | Dyspnea, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-04-06 | Injury | None | Insufficient Information |
| 2022-04-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-04-04 | Injury | None | Perivalvular Leak, Migration |
| 2022-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2022-03-26 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2022-03-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-17 | Injury | None | Migration or Expulsion of Device |
| 2022-03-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-14 | Injury | None | Malposition of Device |
| 2022-03-12 | Malfunction | None | Material Deformation |
| 2022-03-11 | Injury | None | Insufficient Information |
| 2022-03-11 | Injury | None | Material Deformation |
| 2022-03-09 | Death | None | Material Split, Cut or Torn |
| 2022-03-09 | Malfunction | None | Material Deformation |
| 2022-03-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-04 | Injury | None | Migration |
| 2022-03-04 | Injury | None | Fluid/Blood Leak |
| 2022-03-02 | Injury | None | Material Deformation |
| 2022-03-02 | Injury | None | Material Deformation |
| 2022-03-01 | Injury | None | Adverse Event Without Identified Device or Use Problem, Insufficient Information |
| 2022-03-01 | Injury | Cusp Tear | Difficult to Open or Close |
| 2022-02-28 | Injury | None | Perivalvular Leak, Migration |
| 2022-02-28 | Malfunction | None | Material Deformation |
| 2022-02-23 | Malfunction | None | Material Deformation |
| 2022-02-23 | Malfunction | None | Difficult or Delayed Positioning, Difficult to Remove |
| 2022-02-22 | Injury | None | Perivalvular Leak |
| 2022-01-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-24 | Death | Vascular Dissection | Adverse Event Without Identified Device or Use Problem |
| 2022-01-10 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-01-05 | Injury | None | Perivalvular Leak |
| 2021-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-11-20 | Injury | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2021-11-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-11-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-10-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-07-16 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2021-07-01 | Injury | Insufficient Information | Perivalvular Leak |
| 2021-06-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-06-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-05-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-05-18 | Injury | Insufficient Information | Perivalvular Leak |
| 2021-05-18 | Death | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2021-04-13 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2021-04-07 | Injury | Presyncope, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2021-03-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-03-01 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2021-02-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-01-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2020-10-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2020-07-07 | Death | Vascular Dissection | Material Deformation |
| 2020-02-27 | Injury | None | Perivalvular Leak, Adverse Event Without Identified Device or Use Problem |
| 2019-08-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-24 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2019-07-18 | Injury | Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2019-07-17 | Injury | None | Leak/Splash, Adverse Event Without Identified Device or Use Problem |
| 2019-07-16 | Injury | None | Adverse Event Without Identified Device or Use Problem, Physical Resistance/Sticking |
| 2019-07-11 | Injury | None | Electrical /Electronic Property Problem, Adverse Event Without Identified Device or Use Problem |
| 2019-06-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-06 | Injury | None | Complete Blockage, Device Dislodged or Dislocated |
| 2019-06-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-02 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-17 | Injury | None | Coagulation in Device or Device Ingredient, Adverse Event Without Identified Device or Use Problem |
| 2019-04-17 | Injury | None | Adverse Event Without Identified Device or Use Problem, Appropriate Term/Code Not Available |
| 2019-04-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-11 | Injury | None | Perivalvular Leak, Obstruction of Flow, Malposition of Device, Positioning Problem |
| 2019-04-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-10 | Death | None | Unintended Ejection, Positioning Problem |
| 2019-04-10 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-10 | Death | None | Inflation Problem, Device Slipped, Obstruction of Flow, Difficult to Advance, Migration |
| 2019-04-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-03 | Injury | None | Malposition of Device, Migration, Physical Resistance/Sticking |
| 2019-03-27 | Injury | None | Difficult to Advance, Adverse Event Without Identified Device or Use Problem |
| 2019-03-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-21 | Injury | None | Device Dislodged or Dislocated, Migration |
| 2019-03-14 | Injury | None | Fluid/Blood Leak, Perivalvular Leak |
| 2019-03-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-05 | Injury | None | Break, Activation, Positioning or Separation Problem, Material Deformation, Migration |
| 2019-03-05 | Death | None | Malposition of Device, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2019-03-03 | Injury | None | Fluid/Blood Leak, Incomplete Coaptation, Therapeutic or Diagnostic Output Failure |
| 2019-02-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-19 | Injury | None | Insufficient Information, Appropriate Term/Code Not Available |
| 2019-02-18 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-18 | Injury | None | Malposition of Device, Adverse Event Without Identified Device or Use Problem |
| 2019-02-12 | Injury | None | Leak/Splash, Perivalvular Leak, Malposition of Device, Appropriate Term/Code Not Available |
| 2019-02-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-05 | Injury | None | Adverse Event Without Identified Device or Use Problem, Positioning Problem |
| 2019-02-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-29 | Injury | None | Calcified, Fluid/Blood Leak, Perivalvular Leak, Insufficient Information |
| 2019-01-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-16 | Injury | None | Failure to Capture, Pacing Problem, Adverse Event Without Identified Device or Use Problem |
| 2009-07-01 | Injury | None | Migration |