REPLACEMENT HEART VALVE
This device is manufactured by EDWARDS LIFE SCIENCES, EDWARDS LIFESCIENCES, EDWARDS LIFESCIENCES CORP, EDWRADS LIFESCIENCES.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Thrombosis/Thrombus | 3 | Patient |
| 2024 | Tachycardia | 1 | Patient |
| 2024 | Syncope/Fainting | 1 | Patient |
| 2024 | Swelling/ Edema | 3 | Patient |
| 2024 | Pulmonary Edema | 1 | Patient |
| 2024 | Presyncope | 1 | Patient |
| 2024 | Malaise | 1 | Patient |
| 2024 | Insufficient Information | 81 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 43 | Patient |
| 2024 | Fatigue | 5 | Patient |
| 2024 | Endocarditis | 1 | Patient |
| 2024 | Dyspnea | 46 | Patient |
| 2024 | Dizziness | 2 | Patient |
| 2024 | Chest Pain | 6 | Patient |
| 2024 | Cardiogenic Shock | 1 | Patient |
| 2024 | Perivalvular Leak | 1 | Device |
| 2024 | Patient Device Interaction Problem | 7 | Device |
| 2024 | Insufficient Information | 33 | Device |
| 2024 | Incomplete Coaptation | 1 | Device |
| 2024 | Gradient Increase | 6 | Device |
| 2024 | Fluid/Blood Leak | 5 | Device |
| 2024 | Device Stenosis | 34 | Device |
| 2024 | Degraded | 16 | Device |
| 2024 | Central Regurgitation | 11 | Device |
| 2024 | Calcified | 19 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2023 | Transient Ischemic Attack | 1 | Patient |
| 2023 | Thrombosis/Thrombus | 4 | Patient |
| 2023 | Syncope/Fainting | 4 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Shock | 1 | Patient |
| 2023 | Lethargy | 2 | Patient |
| 2023 | Insufficient Information | 104 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 52 | Patient |
| 2023 | Fatigue | 7 | Patient |
| 2023 | Endocarditis | 4 | Patient |
| 2023 | Dyspnea | 54 | Patient |
| 2023 | Dizziness | 3 | Patient |
| 2023 | Chest Pain | 3 | Patient |
| 2023 | Thickening of Material | 2 | Device |
| 2023 | Perivalvular Leak | 1 | Device |
| 2023 | Patient Device Interaction Problem | 7 | Device |
| 2023 | Microbial Contamination of Device | 1 | Device |
| 2023 | Mechanical Jam | 1 | Device |
| 2023 | Material Split, Cut or Torn | 1 | Device |
| 2023 | Insufficient Information | 53 | Device |
| 2023 | Incomplete Coaptation | 2 | Device |
| 2023 | Gradient Increase | 77 | Device |
| 2023 | Fluid/Blood Leak | 43 | Device |
| 2023 | Entrapment of Device | 2 | Device |
| 2023 | Difficult to Open or Close | 7 | Device |
| 2023 | Device Stenosis | 24 | Device |
| 2023 | Degraded | 27 | Device |
| 2023 | Central Regurgitation | 5 | Device |
| 2023 | Calcified | 23 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2022 | Pseudoaneurysm | 1 | Patient |
| 2022 | Insufficient Information | 15 | Patient |
| 2022 | Heart Failure/Congestive Heart Failure | 6 | Patient |
| 2022 | Fatigue | 2 | Patient |
| 2022 | Endocarditis | 1 | Patient |
| 2022 | Dyspnea | 9 | Patient |
| 2022 | Perivalvular Leak | 4 | Device |
| 2022 | Patient-Device Incompatibility | 1 | Device |
| 2022 | Patient Device Interaction Problem | 9 | Device |
| 2022 | Nonstandard Device | 1 | Device |
| 2022 | Material Too Rigid or Stiff | 1 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Material Perforation | 1 | Device |
| 2022 | Insufficient Information | 30 | Device |
| 2022 | Gradient Increase | 56 | Device |
| 2022 | Fluid/Blood Leak | 40 | Device |
| 2022 | Entrapment of Device | 2 | Device |
| 2022 | Difficult to Open or Close | 14 | Device |
| 2022 | Device Stenosis | 2 | Device |
| 2022 | Degraded | 19 | Device |
| 2022 | Calcified | 17 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Thickening of Material | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Gradient Increase | 1 | Device |
| 2021 | Difficult to Open or Close | 1 | Device |
| 2021 | Degraded | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |