AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
This device is manufactured by MEDTRONIC HEART VALVES DIVISION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vascular Dissection | 1 | Patient |
| 2024 | Valvular Insufficiency/ Regurgitation | 5 | Patient |
| 2024 | Thrombosis/Thrombus | 4 | Patient |
| 2024 | Stroke/CVA | 2 | Patient |
| 2024 | Shock | 1 | Patient |
| 2024 | Obstruction/Occlusion | 2 | Patient |
| 2024 | Non specific EKG/ECG Changes | 3 | Patient |
| 2024 | Myocardial Infarction | 1 | Patient |
| 2024 | Low Cardiac Output | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2024 | Loss of consciousness | 1 | Patient |
| 2024 | Insufficient Information | 6 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 4 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Corneal Pannus | 1 | Patient |
| 2024 | Cardiovascular Insufficiency | 1 | Patient |
| 2024 | Cardiac Arrest | 3 | Patient |
| 2024 | Calcium Deposits/Calcification | 1 | Patient |
| 2024 | Aortic Valve Stenosis | 7 | Patient |
| 2024 | Aortic Valve Insufficiency/ Regurgitation | 9 | Patient |
| 2024 | Thickening of Material | 4 | Device |
| 2024 | Perivalvular Leak | 3 | Device |
| 2024 | Patient Device Interaction Problem | 12 | Device |
| 2024 | Material Invagination | 4 | Device |
| 2024 | Malposition of Device | 1 | Device |
| 2024 | Insufficient Information | 10 | Device |
| 2024 | Incomplete Coaptation | 1 | Device |
| 2024 | Inadequacy of Device Shape and/or Size | 2 | Device |
| 2024 | Gradient Increase | 2 | Device |
| 2024 | Fluid/Blood Leak | 3 | Device |
| 2024 | Difficult or Delayed Positioning | 1 | Device |
| 2024 | Device Stenosis | 5 | Device |
| 2024 | Device Dislodged or Dislocated | 6 | Device |
| 2024 | Degraded | 2 | Device |
| 2024 | Central Regurgitation | 7 | Device |
| 2024 | Calcified | 3 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2024 | Activation Failure | 2 | Device |
| 2023 | Valvular Insufficiency/ Regurgitation | 8 | Patient |
| 2023 | Urinary Tract Infection | 1 | Patient |
| 2023 | Unspecified Tissue Injury | 1 | Patient |
| 2023 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Transient Ischemic Attack | 1 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Stroke/CVA | 6 | Patient |
| 2023 | Septic Shock | 1 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Rupture | 1 | Patient |
| 2023 | Respiratory Failure | 2 | Patient |
| 2023 | Renal Impairment | 1 | Patient |
| 2023 | Pulmonary Edema | 1 | Patient |
| 2023 | Pneumonia | 1 | Patient |
| 2023 | Pleural Effusion | 1 | Patient |
| 2023 | Pericardial Effusion | 1 | Patient |
| 2023 | Paresthesia | 1 | Patient |
| 2023 | Obstruction/Occlusion | 1 | Patient |
| 2023 | Numbness | 1 | Patient |
| 2023 | Non specific EKG/ECG Changes | 9 | Patient |
| 2023 | Myocardial Infarction | 3 | Patient |
| 2023 | Muscle Weakness/Atrophy | 1 | Patient |
| 2023 | Mitral Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2023 | Ischemic Heart Disease | 1 | Patient |
| 2023 | Insufficient Information | 9 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 3 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 6 | Patient |
| 2023 | Endocarditis | 1 | Patient |
| 2023 | Dyspnea | 6 | Patient |
| 2023 | Cusp Tear | 2 | Patient |
| 2023 | Cardiovascular Insufficiency | 2 | Patient |
| 2023 | Cardiac Tamponade | 1 | Patient |
| 2023 | Cardiac Arrest | 9 | Patient |
| 2023 | Calcium Deposits/Calcification | 1 | Patient |
| 2023 | Bradycardia | 1 | Patient |
| 2023 | Atrial Fibrillation | 2 | Patient |
| 2023 | Aortic Valve Stenosis | 7 | Patient |
| 2023 | Aortic Valve Insufficiency/ Regurgitation | 16 | Patient |
| 2023 | Thickening of Material | 1 | Device |
| 2023 | Structural Problem | 1 | Device |
| 2023 | Stretched | 1 | Device |
| 2023 | Perivalvular Leak | 7 | Device |
| 2023 | Patient Device Interaction Problem | 7 | Device |
| 2023 | Material Split, Cut or Torn | 1 | Device |
| 2023 | Material Invagination | 2 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Insufficient Information | 24 | Device |
| 2023 | Incomplete Coaptation | 2 | Device |
| 2023 | Gradient Increase | 5 | Device |
| 2023 | Fluid/Blood Leak | 4 | Device |
| 2023 | Device Stenosis | 2 | Device |
| 2023 | Device Dislodged or Dislocated | 7 | Device |
| 2023 | Degraded | 5 | Device |
| 2023 | Central Regurgitation | 6 | Device |
| 2023 | Backflow | 3 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2023 | Activation Failure | 1 | Device |
| 2022 | Valvular Insufficiency/ Regurgitation | 1 | Patient |
| 2022 | Unspecified Infection | 2 | Patient |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Stroke/CVA | 1 | Patient |
| 2022 | Septic Shock | 1 | Patient |
| 2022 | Sepsis | 1 | Patient |
| 2022 | Pneumonia | 1 | Patient |
| 2022 | Non specific EKG/ECG Changes | 5 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Inflammation | 1 | Patient |
| 2022 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2022 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2022 | Heart Block | 2 | Patient |
| 2022 | Fatigue | 1 | Patient |
| 2022 | Dyspnea | 2 | Patient |
| 2022 | Dizziness | 1 | Patient |
| 2022 | Diaphoresis | 1 | Patient |
| 2022 | Chest Pain | 1 | Patient |
| 2022 | Cardiac Enzyme Elevation | 1 | Patient |
| 2022 | Bradycardia | 1 | Patient |
| 2022 | Anemia | 1 | Patient |
| 2022 | Perivalvular Leak | 9 | Device |
| 2022 | Patient Device Interaction Problem | 6 | Device |
| 2022 | Partial Blockage | 1 | Device |
| 2022 | Migration | 1 | Device |
| 2022 | Insufficient Information | 48 | Device |
| 2022 | Gradient Increase | 3 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Device Stenosis | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 7 | Device |
| 2022 | Device Appears to Trigger Rejection | 1 | Device |
| 2022 | Degraded | 2 | Device |
| 2022 | Calcified | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2022 | Activation Problem | 1 | Device |
| 2022 | Activation Failure | 1 | Device |
| 2021 | Visual Disturbances | 1 | Patient |
| 2021 | Pulmonary Edema | 1 | Patient |
| 2021 | Pain | 1 | Patient |
| 2021 | Non specific EKG/ECG Changes | 4 | Patient |
| 2021 | Muscle Weakness/Atrophy | 1 | Patient |
| 2021 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | High Blood Pressure/ Hypertension | 2 | Patient |
| 2021 | Hemorrhagic Stroke | 1 | Patient |
| 2021 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2021 | Heart Block | 1 | Patient |
| 2021 | Dyspnea | 1 | Patient |
| 2021 | Dizziness | 1 | Patient |
| 2021 | Bradycardia | 1 | Patient |
| 2021 | Atrial Fibrillation | 1 | Patient |
| 2021 | Patient Device Interaction Problem | 4 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Gradient Increase | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2020 | Thrombosis/Thrombus | 1 | Patient |
| 2020 | Thromboembolism | 1 | Patient |
| 2020 | Stroke/CVA | 1 | Patient |
| 2020 | Shaking/Tremors | 1 | Patient |
| 2020 | Non specific EKG/ECG Changes | 1 | Patient |
| 2020 | Insufficient Information | 2 | Patient |
| 2020 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2020 | Heart Block | 2 | Patient |
| 2020 | Dysphasia | 1 | Patient |
| 2020 | Bradycardia | 1 | Patient |
| 2020 | Thickening of Material | 1 | Device |
| 2020 | Patient Device Interaction Problem | 3 | Device |
| 2020 | Insufficient Information | 1 | Device |
| 2020 | Gradient Increase | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 10 | Device |