REPLACEMENT HEART VALVE
This device is manufactured by EDWARDS LIFESCIENCES, EDWARDS LIFESCIENCES CORP.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Swelling/ Edema | 1 | Patient |
| 2024 | Insufficient Information | 8 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 5 | Patient |
| 2024 | Dyspnea | 6 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Patient Device Interaction Problem | 1 | Device |
| 2024 | Insufficient Information | 2 | Device |
| 2024 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2024 | Gradient Increase | 1 | Device |
| 2024 | Device Stenosis | 6 | Device |
| 2024 | Central Regurgitation | 2 | Device |
| 2024 | Calcified | 4 | Device |
| 2023 | Insufficient Information | 5 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Insufficient Information | 2 | Device |
| 2023 | Gradient Increase | 4 | Device |
| 2023 | Fluid/Blood Leak | 4 | Device |
| 2023 | Difficult to Open or Close | 1 | Device |
| 2023 | Device Stenosis | 1 | Device |
| 2023 | Degraded | 2 | Device |
| 2023 | Calcified | 1 | Device |
| 2022 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2022 | Thickening of Material | 1 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Gradient Increase | 3 | Device |
| 2022 | Fluid/Blood Leak | 1 | Device |
| 2022 | Difficult to Open or Close | 1 | Device |
| 2022 | Degraded | 1 | Device |
| 2022 | Calcified | 2 | Device |