AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
This device is manufactured by EDWARDS LIFESCIENCES.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Insufficient Information | 7 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 3 | Patient |
| 2024 | Heart Block | 1 | Patient |
| 2024 | Dyspnea | 5 | Patient |
| 2024 | Balance Problems | 1 | Patient |
| 2024 | Gradient Increase | 1 | Device |
| 2024 | Fluid/Blood Leak | 1 | Device |
| 2024 | Device Stenosis | 4 | Device |
| 2024 | Degraded | 6 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Mitral Valve Stenosis | 1 | Patient |
| 2023 | Ischemia Stroke | 1 | Patient |
| 2023 | Insufficient Information | 16 | Patient |
| 2023 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 6 | Patient |
| 2023 | Heart Block | 2 | Patient |
| 2023 | Endocarditis | 1 | Patient |
| 2023 | Dyspnea | 6 | Patient |
| 2023 | Appropriate Term / Code Not Available | 2 | Patient |
| 2023 | Perivalvular Leak | 2 | Device |
| 2023 | Insufficient Information | 4 | Device |
| 2023 | Gradient Increase | 4 | Device |
| 2023 | Difficult to Open or Close | 4 | Device |
| 2023 | Device Stenosis | 4 | Device |
| 2023 | Degraded | 12 | Device |
| 2023 | Calcified | 8 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2022 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Gradient Increase | 1 | Device |
| 2022 | Fluid/Blood Leak | 3 | Device |
| 2022 | Difficult to Open or Close | 1 | Device |
| 2022 | Degraded | 6 | Device |
| 2022 | Calcified | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Perivalvular Leak | 1 | Device |
| 2020 | Calcified | 1 | Device |