REPLACEMENT HEART VALVE
This device is manufactured by CARPENTIER EDWARDS, EDWARDS LIFESCIENCES.
The following problems were reported about this device:
Year | Description | Events/year | Type |
---|---|---|---|
2024 | Syncope/Fainting | 1 | Patient |
2024 | Insufficient Information | 17 | Patient |
2024 | Heart Failure/Congestive Heart Failure | 6 | Patient |
2024 | Fatigue | 1 | Patient |
2024 | Dyspnea | 6 | Patient |
2024 | Chest Pain | 1 | Patient |
2024 | Cardiogenic Shock | 1 | Patient |
2024 | Cardiac Arrest | 1 | Patient |
2024 | Perivalvular Leak | 1 | Device |
2024 | Patient Device Interaction Problem | 1 | Device |
2024 | Insufficient Information | 9 | Device |
2024 | Gradient Increase | 5 | Device |
2024 | Fluid/Blood Leak | 2 | Device |
2024 | Device Stenosis | 5 | Device |
2024 | Degraded | 2 | Device |
2024 | Central Regurgitation | 3 | Device |
2024 | Calcified | 1 | Device |
2023 | Syncope/Fainting | 1 | Patient |
2023 | Insufficient Information | 35 | Patient |
2023 | Heart Failure/Congestive Heart Failure | 10 | Patient |
2023 | Fatigue | 2 | Patient |
2023 | Endocarditis | 2 | Patient |
2023 | Dyspnea | 16 | Patient |
2023 | Dizziness | 2 | Patient |
2023 | Chest Pain | 4 | Patient |
2023 | Perivalvular Leak | 1 | Device |
2023 | Patient Device Interaction Problem | 1 | Device |
2023 | Insufficient Information | 29 | Device |
2023 | Gradient Increase | 15 | Device |
2023 | Fluid/Blood Leak | 5 | Device |
2023 | Difficult to Open or Close | 1 | Device |
2023 | Device Stenosis | 3 | Device |
2023 | Degraded | 4 | Device |
2023 | Calcified | 6 | Device |
2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
2022 | Insufficient Information | 3 | Patient |
2022 | Heart Failure/Congestive Heart Failure | 1 | Patient |
2022 | Dyspnea | 2 | Patient |
2022 | Chest Pain | 1 | Patient |
2022 | Perivalvular Leak | 1 | Device |
2022 | Patient Device Interaction Problem | 3 | Device |
2022 | Insufficient Information | 16 | Device |
2022 | Gradient Increase | 22 | Device |
2022 | Fluid/Blood Leak | 4 | Device |
2022 | Difficult to Open or Close | 2 | Device |
2022 | Degraded | 8 | Device |
2022 | Calcified | 7 | Device |
2020 | Insufficient Information | 1 | Patient |
2020 | Heart Failure/Congestive Heart Failure | 1 | Patient |
2020 | Insufficient Information | 1 | Device |
2020 | Gradient Increase | 1 | Device |
2020 | Fluid/Blood Leak | 1 | Device |
2020 | Difficult to Open or Close | 1 | Device |
2020 | Calcified | 1 | Device |