SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL
This device is manufactured by BOSTON SCIENTIFIC CORPORATION.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-22 | Injury | Thrombosis/Thrombus | None |
| 2024-07-18 | Injury | Thrombosis/Thrombus | None |
| 2024-07-18 | Injury | Thrombosis/Thrombus | None |
| 2024-07-15 | Injury | Thrombosis/Thrombus | None |
| 2024-07-11 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-07-09 | Injury | Thrombosis/Thrombus | None |
| 2024-07-08 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Pericarditis | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Transient Ischemic Attack | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Perforation of Vessels | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | Myocardial Infarction | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | Cardiac Arrest | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Cardiac Tamponade | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | Cardiac Tamponade | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Myocardial Infarction | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Endocarditis | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Thrombosis/Thrombus | None |
| 2024-07-08 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Air Embolism | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Thromboembolism | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Pseudoaneurysm | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Injury | Cardiac Arrest | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | Thromboembolism | Adverse Event Without Identified Device or Use Problem |
| 2024-07-08 | Death | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-06-25 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2024-06-25 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-06-25 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2024-06-24 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-06-24 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-06-24 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2024-06-24 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-06-24 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-06-24 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-06-17 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-06-14 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-06-12 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-06-08 | Death | Stroke/CVA, Intracranial Hemorrhage | Adverse Event Without Identified Device or Use Problem |
| 2024-06-04 | Injury | Chest Pain, Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2024-06-03 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-06-03 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-05-31 | Injury | Thrombosis/Thrombus | Difficult to Open or Close |
| 2024-05-29 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-05-24 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-05-23 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-05-21 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-05-20 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-05-19 | Injury | Stroke/CVA, Muscle Weakness/Atrophy, Paresthesia | Adverse Event Without Identified Device or Use Problem |
| 2024-05-18 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-05-17 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-05-16 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-05-13 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-05-09 | Injury | Bradycardia, Asystole | Adverse Event Without Identified Device or Use Problem |
| 2024-05-08 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-05-08 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-05-07 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-04-28 | Injury | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-04-27 | Injury | Transient Ischemic Attack | Adverse Event Without Identified Device or Use Problem |
| 2024-04-22 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-04-22 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-04-19 | Injury | Ischemia Stroke, Thrombosis/Thrombus | Difficult to Open or Close |
| 2024-04-17 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated, Migration |
| 2024-04-17 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-04-17 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-04-17 | Injury | Stroke/CVA, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-04-16 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2024-04-12 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-04-12 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2024-04-12 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-04-12 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-04-12 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-04-12 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-04-10 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-04-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2024-04-08 | Injury | High Blood Pressure/ Hypertension, Paralysis, Dysphasia | Adverse Event Without Identified Device or Use Problem |
| 2024-04-08 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-04-07 | Injury | Cardiac Arrest, Tachycardia, Swelling/ Edema | Adverse Event Without Identified Device or Use Problem |
| 2024-04-05 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-04-05 | Death | Loss of consciousness | Adverse Event Without Identified Device or Use Problem |
| 2024-04-04 | Injury | Thrombosis/Thrombus | None |
| 2024-04-02 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-04-02 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-03-31 | Injury | Chest Pain | None |
| 2024-03-28 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-03-27 | Injury | Thrombosis/Thrombus | None |
| 2024-03-27 | Injury | Low Blood Pressure/ Hypotension, Pericardial Effusion | None |
| 2024-03-26 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-26 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-08 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-07 | Injury | Thrombosis/Thrombus | None |
| 2024-03-01 | Injury | Fistula | Difficult to Open or Close |
| 2024-02-29 | Injury | Thrombosis/Thrombus | None |
| 2024-02-29 | Injury | Low Blood Pressure/ Hypotension, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-02-28 | Death | Air Embolism, Respiratory Insufficiency | None |
| 2024-02-27 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-02-27 | Injury | Low Blood Pressure/ Hypotension, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-02-27 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-02-26 | Injury | Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem |
| 2024-02-26 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-02-26 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-02-26 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-02-22 | Death | Dyspnea, Unspecified Tissue Injury | Device Dislodged or Dislocated |
| 2024-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Flush, Material Integrity Problem, Adverse Event Without Identified Device or Use Problem |
| 2024-02-20 | Injury | Low Blood Pressure/ Hypotension, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-02-19 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-02-19 | Injury | Low Blood Pressure/ Hypotension, Pericardial Effusion | Device Dislodged or Dislocated |
| 2024-02-16 | Injury | Thrombosis/Thrombus | Migration |
| 2024-02-15 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-02-15 | Injury | Muscle Weakness/Atrophy, Transient Ischemic Attack, Dizziness | Adverse Event Without Identified Device or Use Problem |
| 2024-02-12 | Injury | Low Blood Pressure/ Hypotension, Cardiac Perforation, Pericardial Effusion, No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-02-11 | Injury | No Clinical Signs, Symptoms or Conditions | Use of Device Problem |
| 2024-02-08 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-02-07 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-02-07 | Injury | Chest Pain, Dyspnea, Muscle Weakness/Atrophy, Discomfort, Obstruction/Occlusion | Device Dislodged or Dislocated |
| 2024-02-06 | Injury | Air Embolism, Bradycardia, Non specific EKG/ECG Changes, Low Blood Pressure/ Hypotension | Adverse Event Without Identified Device or Use Problem |
| 2024-02-06 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-02-05 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2024-02-05 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2024-02-02 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2024-02-02 | Injury | Hypersensitivity/Allergic reaction, No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-02-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-31 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2024-01-31 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-01-25 | Injury | Non specific EKG/ECG Changes, Low Blood Pressure/ Hypotension, Obstruction/Occlusion | Adverse Event Without Identified Device or Use Problem |
| 2024-01-22 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-18 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-01-18 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-18 | Death | No Clinical Signs, Symptoms or Conditions | Migration |
| 2024-01-18 | Death | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-01-17 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Integrity Problem |
| 2024-01-17 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | Pseudoaneurysm | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | Thromboembolism | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-01-17 | Death | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | Intracranial Hemorrhage | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | Air Embolism | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | Cardiac Tamponade | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | Cardiac Tamponade | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | Cardiac Arrest | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | Endocarditis | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | Cardiac Arrest | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | Fistula | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | Air Embolism | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-01-17 | Death | Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Injury | Pericarditis | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Death | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Injury | Perforation of Vessels | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2024-01-16 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-01-16 | Injury | Hemorrhage/Blood Loss/Bleeding | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Injury | Myocardial Infarction | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Injury | Retroperitoneal Hemorrhage | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Injury | Hematoma | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Injury | Transient Ischemic Attack | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Injury | Cardiac Tamponade | Adverse Event Without Identified Device or Use Problem |
| 2024-01-16 | Injury | Cardiac Arrest | Adverse Event Without Identified Device or Use Problem |
| 2024-01-14 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-01-13 | Injury | Perforation of Vessels | Adverse Event Without Identified Device or Use Problem |
| 2024-01-13 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2024-01-12 | Injury | Stroke/CVA | Difficult to Open or Close |
| 2024-01-12 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-11 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-11 | Malfunction | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2024-01-10 | Injury | Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-01-10 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2024-01-09 | Injury | Low Blood Pressure/ Hypotension, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-01-09 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2024-01-09 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-01-08 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-01-05 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-01-05 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-01-04 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2024-01-03 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2024-01-01 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-01-01 | Injury | Stroke/CVA, Transient Ischemic Attack | Adverse Event Without Identified Device or Use Problem |
| 2024-01-01 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2024-01-01 | Injury | Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-12-26 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-12-22 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-12-21 | Injury | Stroke/CVA, Muscle Weakness/Atrophy, Thrombosis/Thrombus, Facial Paralysis | Adverse Event Without Identified Device or Use Problem |
| 2023-12-20 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-12-20 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-12-20 | Injury | Pericardial Effusion | None |
| 2023-12-19 | Injury | Cardiac Arrest, Chest Pain, Non specific EKG/ECG Changes | None |
| 2023-12-19 | Death | Stroke/CVA, Low Blood Pressure/ Hypotension, Unspecified Tissue Injury | None |
| 2023-12-18 | Injury | Thrombosis/Thrombus | None |
| 2023-12-18 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-18 | Injury | Stroke/CVA, Myocardial Infarction | None |
| 2023-12-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-15 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-12-15 | Injury | Thrombosis/Thrombus | None |
| 2023-12-15 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-12-14 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-12-13 | Injury | Thrombosis/Thrombus | None |
| 2023-12-13 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2023-12-13 | Injury | Thrombosis/Thrombus | None |
| 2023-12-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-11 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-12-11 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-10 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-12-09 | Death | Bacterial Infection, Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-12-07 | Death | Cardiac Arrest, Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2023-12-06 | Injury | Stroke/CVA | None |
| 2023-11-29 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-11-27 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2023-11-09 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-11-09 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-11-09 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-11-08 | Injury | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-11-08 | Injury | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-11-03 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-11-03 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-11-02 | Injury | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-11-02 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-11-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-31 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-10-31 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-10-30 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-28 | Injury | Stroke/CVA, Loss of Vision | Adverse Event Without Identified Device or Use Problem |
| 2023-10-27 | Death | Abdominal Pain, Cardiac Arrest, Chest Pain | Adverse Event Without Identified Device or Use Problem |
| 2023-10-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Leak/Splash |
| 2023-10-25 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-10-24 | Injury | Insufficient Information | Adverse Event Without Identified Device or Use Problem |
| 2023-10-24 | Injury | Stroke/CVA, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-24 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-24 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-23 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-23 | Injury | Thrombosis/Thrombus | None |
| 2023-10-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Integrity Problem |
| 2023-10-20 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2023-10-20 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-10-18 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-10-17 | Injury | Stroke/CVA | Migration |
| 2023-10-17 | Injury | Cardiac Arrest, Low Blood Pressure/ Hypotension, Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-10-15 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-10-15 | Death | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-10-13 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-10-13 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-10-13 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-13 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-10-13 | Injury | Unspecified Tissue Injury | Adverse Event Without Identified Device or Use Problem |
| 2023-10-12 | Injury | Low Blood Pressure/ Hypotension, Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-10-12 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-10-12 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-10-12 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-12 | Injury | No Clinical Signs, Symptoms or Conditions | Material Integrity Problem, Migration |
| 2023-10-11 | Injury | Respiratory Insufficiency | Adverse Event Without Identified Device or Use Problem |
| 2023-10-11 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-10 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-10 | Death | Low Blood Pressure/ Hypotension, Tachycardia, Cardiac Perforation, Pericardial Effusion | Migration |
| 2023-10-10 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-10-09 | Injury | Transient Ischemic Attack, Numbness | Adverse Event Without Identified Device or Use Problem |
| 2023-10-09 | Death | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-10-08 | Injury | Atrial Fibrillation, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-10-07 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-10-06 | Injury | Low Blood Pressure/ Hypotension, Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-10-06 | Death | Pain, Renal Failure | Device Dislodged or Dislocated |
| 2023-10-06 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-10-05 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-10-03 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-10-01 | Injury | Stroke/CVA, Thrombosis/Thrombus | None |
| 2023-09-29 | Injury | Stroke/CVA, Muscle Weakness/Atrophy, Transient Ischemic Attack, Numbness, Speech Disorder | Adverse Event Without Identified Device or Use Problem |
| 2023-09-28 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2023-09-27 | Injury | Renal Failure | Device Dislodged or Dislocated |
| 2023-09-25 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated, Migration |
| 2023-09-25 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-09-21 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-09-21 | Death | Cardiac Arrest, Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-09-20 | Injury | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-09-18 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2023-09-18 | Injury | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-09-15 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-09-14 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-09-12 | Death | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-09-11 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-09-11 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-09-11 | Injury | Low Blood Pressure/ Hypotension, Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-09-09 | Injury | Thrombosis/Thrombus, Pericarditis | Adverse Event Without Identified Device or Use Problem |
| 2023-09-08 | Injury | Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion | Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2023-09-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-09-08 | Injury | Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-09-07 | Injury | Chest Pain, Dyspnea | Device Dislodged or Dislocated |
| 2023-09-06 | Injury | Stroke/CVA, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-09-01 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-09-01 | Injury | Stroke/CVA, Loss of Vision, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-31 | Injury | Endocarditis, Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-08-30 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-08-30 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-29 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-08-29 | Injury | Thrombosis/Thrombus | Migration |
| 2023-08-29 | Death | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-27 | Injury | Dyspnea, Fistula | Difficult to Open or Close |
| 2023-08-25 | Injury | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component, Device Dislodged or Dislocated |
| 2023-08-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-08-24 | Injury | Stroke/CVA, Thrombosis/Thrombus | Difficult to Open or Close |
| 2023-08-21 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-08-20 | Injury | Atrial Fibrillation, Transient Ischemic Attack | Adverse Event Without Identified Device or Use Problem |
| 2023-08-18 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-08-18 | Injury | Cardiac Arrest, Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-08-18 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-17 | Injury | High Blood Pressure/ Hypertension, Pericardial Effusion | Difficult to Open or Close |
| 2023-08-17 | Injury | Low Blood Pressure/ Hypotension, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-08-16 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-08-14 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-08-12 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-11 | Injury | Transient Ischemic Attack | Adverse Event Without Identified Device or Use Problem |
| 2023-08-11 | Death | Cardiac Arrest | Adverse Event Without Identified Device or Use Problem |
| 2023-08-11 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-08-10 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-08 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-07 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-08-06 | Injury | Dysphasia | Adverse Event Without Identified Device or Use Problem |
| 2023-08-04 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-04 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2023-08-04 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-03 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-08-03 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-08-02 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-08-02 | Injury | Thrombosis/Thrombus | None |
| 2023-08-02 | Death | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-08-01 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-08-01 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-08-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-31 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-28 | Injury | No Clinical Signs, Symptoms or Conditions | Device-Device Incompatibility, Device Dislodged or Dislocated |
| 2023-07-28 | Injury | Stroke/CVA | Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2023-07-27 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-07-27 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-07-27 | Injury | Hemorrhage/Blood Loss/Bleeding, Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem |
| 2023-07-26 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-07-25 | Injury | Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-07-24 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-07-20 | Injury | Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2023-07-20 | Injury | Chest Pain, Tachycardia, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-07-20 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-20 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-07-20 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-07-20 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-07-20 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-19 | Injury | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-07-19 | Injury | Stroke/CVA, Muscle Weakness/Atrophy, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-17 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-13 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-07-13 | Injury | Stroke/CVA, Muscle Weakness/Atrophy, Speech Disorder | Adverse Event Without Identified Device or Use Problem |
| 2023-07-13 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-07-13 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-07-13 | Injury | Stroke/CVA, Thromboembolism, Speech Disorder | Adverse Event Without Identified Device or Use Problem |
| 2023-07-12 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-12 | Death | Low Blood Pressure/ Hypotension, Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-07-11 | Injury | Air Embolism, Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-07-11 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-07-11 | Injury | Arrhythmia, Chest Pain | Adverse Event Without Identified Device or Use Problem |
| 2023-07-03 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-01 | Injury | Chest Pain, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-07-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-30 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-30 | Injury | Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-06-30 | Injury | Stroke/CVA, Thromboembolism | Adverse Event Without Identified Device or Use Problem |
| 2023-06-29 | Injury | Cardiac Perforation, Thrombosis/Thrombus | Difficult to Open or Close, Adverse Event Without Identified Device or Use Problem |
| 2023-06-28 | Injury | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-06-27 | Injury | Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-06-26 | Injury | Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-06-22 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-22 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-06-22 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-20 | Injury | Stroke/CVA, Transient Ischemic Attack, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-16 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-06-15 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-06-15 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-06-15 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-06-14 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-13 | Injury | Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-06-13 | Injury | Atrial Fibrillation, Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem |
| 2023-06-13 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-06-12 | Death | Low Blood Pressure/ Hypotension, Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-06-10 | Injury | Stroke/CVA, Thrombosis/Thrombus | Difficult to Open or Close |
| 2023-06-09 | Injury | Stroke/CVA, Transient Ischemic Attack, Speech Disorder | Adverse Event Without Identified Device or Use Problem |
| 2023-06-06 | Injury | Transient Ischemic Attack | Adverse Event Without Identified Device or Use Problem |
| 2023-06-06 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-06-05 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-06-05 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-06-05 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-06-05 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-04 | Injury | Syncope/Fainting | Device Dislodged or Dislocated |
| 2023-06-02 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-06-02 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-06-01 | Injury | Transient Ischemic Attack, Thrombosis/Thrombus, Diplopia/Double Vision | Adverse Event Without Identified Device or Use Problem |
| 2023-06-01 | Death | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-06-01 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-06-01 | Injury | Arrhythmia | Adverse Event Without Identified Device or Use Problem |
| 2023-05-31 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-05-31 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-05-31 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-05-31 | Injury | Arrhythmia | Adverse Event Without Identified Device or Use Problem |
| 2023-05-30 | Injury | Discomfort | Device Dislodged or Dislocated |
| 2023-05-30 | Injury | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-05-30 | Injury | Low Blood Pressure/ Hypotension, Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-05-26 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-05-24 | Injury | Stroke/CVA, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-05-21 | Death | Hemorrhage/Blood Loss/Bleeding, Cardiac Perforation | Adverse Event Without Identified Device or Use Problem |
| 2023-05-20 | Injury | Chest Pain, Dizziness, Syncope/Fainting, Speech Disorder, Facial Paralysis | Adverse Event Without Identified Device or Use Problem |
| 2023-05-18 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-05-18 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-05-18 | Injury | Unspecified Tissue Injury | Device Dislodged or Dislocated |
| 2023-05-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Detachment of Device or Device Component |
| 2023-05-18 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-05-17 | Death | Cardiac Arrest, Dyspnea, Loss of consciousness | Adverse Event Without Identified Device or Use Problem |
| 2023-05-17 | Injury | Stroke/CVA, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-05-16 | Injury | Intracranial Hemorrhage | Adverse Event Without Identified Device or Use Problem |
| 2023-05-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Integrity Problem |
| 2023-05-12 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-05-07 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-05-04 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-05-01 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-04-26 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-04-20 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-04-18 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-04-14 | Injury | Stroke/CVA, Loss of Vision, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-04-12 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-04-07 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-03-31 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2023-03-30 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-03-27 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-03-24 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-03-24 | Injury | Transient Ischemic Attack, Diplopia/Double Vision | Adverse Event Without Identified Device or Use Problem |
| 2023-03-22 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-03-22 | Injury | Transient Ischemic Attack | Adverse Event Without Identified Device or Use Problem |
| 2023-03-21 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-03-15 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-03-10 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-03-09 | Injury | Pericardial Effusion | Material Integrity Problem, Activation Failure |
| 2023-03-09 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-03-09 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-03-07 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-03-07 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-03-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Remove, Material Integrity Problem, Activation Failure |
| 2023-03-06 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-03-05 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-03-03 | Death | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-03-02 | Injury | No Clinical Signs, Symptoms or Conditions | Migration |
| 2023-03-02 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-02-21 | Injury | Stroke/CVA, Cognitive Changes, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-02-17 | Injury | Tachycardia, Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-02-16 | Injury | Air Embolism, Non specific EKG/ECG Changes | Adverse Event Without Identified Device or Use Problem |
| 2023-02-16 | Injury | Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion, Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem |
| 2023-02-16 | Injury | Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-02-16 | Injury | Fistula, No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-02-14 | Injury | Thrombosis/Thrombus | Difficult to Open or Close |
| 2023-02-13 | Injury | Stroke/CVA, Loss of Vision, No Clinical Signs, Symptoms or Conditions | Device-Device Incompatibility, Device Dislodged or Dislocated, Migration |
| 2023-02-12 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-02-10 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-02-09 | Injury | Low Blood Pressure/ Hypotension, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-02-07 | Injury | Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion, Heart Failure/Congestive Heart Failure | Adverse Event Without Identified Device or Use Problem |
| 2023-02-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Remove, Material Deformation, Positioning Problem, Physical Resistance/Sticking |
| 2023-02-06 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-02-06 | Injury | Stroke/CVA, Memory Loss/Impairment, Muscle Weakness/Atrophy, Speech Disorder | Adverse Event Without Identified Device or Use Problem |
| 2023-02-03 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-02-02 | Injury | Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-02-02 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2023-01-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Integrity Problem, Adverse Event Without Identified Device or Use Problem |
| 2023-01-27 | Injury | Bradycardia, Low Blood Pressure/ Hypotension | Adverse Event Without Identified Device or Use Problem |
| 2023-01-27 | Injury | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-01-26 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated, Migration |
| 2023-01-25 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-01-24 | Injury | Cardiac Tamponade, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-01-18 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-01-18 | Injury | Pericardial Effusion, No Clinical Signs, Symptoms or Conditions | None |
| 2023-01-18 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2023-01-13 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-01-12 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-01-11 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2023-01-10 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-01-06 | Injury | Dyspnea, Low Blood Pressure/ Hypotension, Pleural Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-01-04 | Injury | Mitral Valve Insufficiency/ Regurgitation | Adverse Event Without Identified Device or Use Problem |
| 2023-01-03 | Injury | Low Blood Pressure/ Hypotension, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2023-01-01 | Injury | Stroke/CVA, Thrombosis/Thrombus | Difficult to Open or Close, Migration |
| 2023-01-01 | Injury | Stroke/CVA, Paralysis | Adverse Event Without Identified Device or Use Problem |
| 2023-01-01 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2023-01-01 | Injury | Air Embolism, Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-01-01 | Death | Air Embolism, Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2023-01-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2023-01-01 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-01-01 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2023-01-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-01-01 | Injury | Stroke/CVA | Difficult to Open or Close |
| 2023-01-01 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2022-12-31 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2022-12-28 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-12-28 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2022-12-27 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-12-27 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2022-12-21 | Injury | Thrombosis/Thrombus | Migration |
| 2022-12-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-12-12 | Injury | Air Embolism, Non specific EKG/ECG Changes, Heart Block | Adverse Event Without Identified Device or Use Problem |
| 2022-12-05 | Injury | None | Difficult to Open or Close, Migration |
| 2022-12-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-18 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-16 | Malfunction | None | Detachment of Device or Device Component |
| 2022-11-13 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-11 | Injury | None | Device Dislodged or Dislocated |
| 2022-11-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-09 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-11-04 | Injury | None | Device Dislodged or Dislocated |
| 2022-11-03 | Injury | None | Device Dislodged or Dislocated |
| 2022-11-03 | Injury | Obstruction/Occlusion, Thromboembolism, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-11-03 | Death | None | Migration |
| 2022-11-02 | Malfunction | None | Detachment of Device or Device Component |
| 2022-10-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-26 | Injury | Cardiac Arrest, Cardiac Tamponade | Adverse Event Without Identified Device or Use Problem |
| 2022-10-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-24 | Injury | Pericarditis | Adverse Event Without Identified Device or Use Problem |
| 2022-10-21 | Death | None | Device Dislodged or Dislocated |
| 2022-10-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-20 | Injury | Pericardial Effusion, Pericarditis | Adverse Event Without Identified Device or Use Problem |
| 2022-10-20 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-18 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-10-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-14 | Injury | None | Migration |
| 2022-10-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-11 | Injury | None | Device-Device Incompatibility, Device Dislodged or Dislocated |
| 2022-10-05 | Injury | None | Migration |
| 2022-10-01 | Injury | Stroke/CVA | Difficult to Open or Close |
| 2022-09-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-22 | Injury | None | Difficult to Open or Close |
| 2022-09-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-08 | Injury | None | Device Dislodged or Dislocated |
| 2022-09-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-01 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2022-08-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-22 | Malfunction | None | Detachment of Device or Device Component |
| 2022-08-22 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-19 | Injury | Cardiac Tamponade, Pericarditis | Adverse Event Without Identified Device or Use Problem |
| 2022-08-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-12 | Injury | None | Device Dislodged or Dislocated |
| 2022-08-11 | Injury | Cardiac Tamponade | Adverse Event Without Identified Device or Use Problem |
| 2022-08-11 | Injury | None | Device Dislodged or Dislocated |
| 2022-08-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-04 | Injury | None | Device Dislodged or Dislocated |
| 2022-07-29 | Injury | Pain, Cardiac Perforation, Pericardial Effusion | Adverse Event Without Identified Device or Use Problem |
| 2022-07-25 | Malfunction | None | Material Integrity Problem |
| 2022-07-14 | Injury | None | Device Dislodged or Dislocated |
| 2022-07-01 | Injury | None | Difficult to Open or Close |
| 2022-06-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-06-07 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-05-23 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2022-04-18 | Injury | None | Detachment of Device or Device Component |
| 2022-04-15 | Injury | None | Difficult to Remove, Detachment of Device or Device Component |
| 2022-04-13 | Injury | None | Device Dislodged or Dislocated |
| 2022-04-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-04-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-04-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-04-08 | Injury | None | Difficult to Open or Close |
| 2022-04-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-04-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-04-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-04-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-31 | Injury | None | Migration |
| 2022-03-25 | Injury | None | 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 |
| 2022-03-23 | Injury | None | Device Dislodged or Dislocated |
| 2022-03-22 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-19 | Injury | None | Migration |
| 2022-03-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-18 | Injury | None | Difficult to Open or Close |
| 2022-03-17 | Injury | None | Migration |
| 2022-03-16 | Malfunction | None | Difficult or Delayed Positioning, Material Integrity Problem |
| 2022-03-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-11 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-11 | Malfunction | None | Material Deformation |
| 2022-03-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-01 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close, Migration |
| 2022-02-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-11 | Injury | Chest Pain, Pericardial Effusion, Pericarditis | Adverse Event Without Identified Device or Use Problem |
| 2022-01-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-01 | Injury | Pain, Obstruction/Occlusion | Device Dislodged or Dislocated |
| 2022-01-01 | Injury | Stroke/CVA | Adverse Event Without Identified Device or Use Problem |
| 2022-01-01 | Injury | No Clinical Signs, Symptoms or Conditions | Difficult to Open or Close |
| 2021-12-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-09-28 | Injury | Dyspnea, Fatigue, No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2021-07-01 | Injury | Atrial Fibrillation, Fatigue, Muscle Weakness/Atrophy | Adverse Event Without Identified Device or Use Problem |
| 2021-05-11 | Injury | Stroke/CVA, Paralysis, Speech Disorder | None |
| 2020-01-01 | Injury | Stroke/CVA, Pain | Device Dislodged or Dislocated |
| 2019-09-03 | Injury | Chest Pain, Pericardial Effusion, Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2019-09-01 | Injury | Pulmonary Embolism, Stroke/CVA, Cardiac Tamponade, Cardiac Perforation, Pericardial Effusion, Thrombosis/Thrombus | Migration |
| 2019-09-01 | Death | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2019-08-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-20 | Malfunction | None | Leak/Splash |
| 2019-08-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-28 | Injury | Bacterial Infection, Stroke/CVA, Fall, Fever, Low Blood Pressure/ Hypotension, Septic Shock | Adverse Event Without Identified Device or Use Problem |
| 2019-04-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-10 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-10 | Injury | None | Difficult to Open or Close, Adverse Event Without Identified Device or Use Problem |
| 2018-09-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Transient Ischemic Attack, Cardiac Tamponade | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |
| 2015-10-01 | Injury | Thrombosis/Thrombus | Adverse Event Without Identified Device or Use Problem |