REPLACEMENT HEART VALVE
This device is manufactured by EDWARDS LIFESCIENCES, EDWRADS LIFESCIENCES, REPLACEMENT HEART VALVE.
The following problems were reported about this device:
Year | Description | Events/year | Type |
---|---|---|---|
2024 | Thrombosis/Thrombus | 2 | Patient |
2024 | Syncope/Fainting | 3 | Patient |
2024 | Swelling/ Edema | 3 | Patient |
2024 | Presyncope | 3 | Patient |
2024 | Obstruction/Occlusion | 2 | Patient |
2024 | Insufficient Information | 124 | Patient |
2024 | Hypervolemia | 1 | Patient |
2024 | Heart Failure/Congestive Heart Failure | 46 | Patient |
2024 | Fatigue | 5 | Patient |
2024 | Endocarditis | 3 | Patient |
2024 | Dyspnea | 58 | Patient |
2024 | Dizziness | 2 | Patient |
2024 | Chest Pain | 9 | Patient |
2024 | Bacterial Infection | 1 | Patient |
2024 | Thickening of Material | 1 | Device |
2024 | Perivalvular Leak | 2 | Device |
2024 | Patient-Device Incompatibility | 1 | Device |
2024 | Patient Device Interaction Problem | 7 | Device |
2024 | Particulates | 1 | Device |
2024 | Microbial Contamination of Device | 1 | Device |
2024 | Material Split, Cut or Torn | 1 | Device |
2024 | Insufficient Information | 59 | Device |
2024 | Inadequacy of Device Shape and/or Size | 2 | Device |
2024 | Gradient Increase | 11 | Device |
2024 | Fluid/Blood Leak | 5 | Device |
2024 | Difficult to Open or Close | 1 | Device |
2024 | Device Stenosis | 42 | Device |
2024 | Device Handling Problem | 1 | Device |
2024 | Degraded | 16 | Device |
2024 | Central Regurgitation | 10 | Device |
2024 | Calcified | 19 | Device |
2024 | Break | 1 | Device |
2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
2023 | Vasodilatation | 1 | Patient |
2023 | Thrombosis/Thrombus | 1 | Patient |
2023 | Syncope/Fainting | 8 | Patient |
2023 | Swelling/ Edema | 3 | Patient |
2023 | Pseudoaneurysm | 1 | Patient |
2023 | Presyncope | 1 | Patient |
2023 | Peripheral Edema | 3 | Patient |
2023 | Mitral Valve Insufficiency/ Regurgitation | 1 | Patient |
2023 | Malaise | 2 | Patient |
2023 | Ischemia Stroke | 1 | Patient |
2023 | Insufficient Information | 171 | Patient |
2023 | Heart Failure/Congestive Heart Failure | 67 | Patient |
2023 | Heart Block | 1 | Patient |
2023 | Fever | 3 | Patient |
2023 | Fatigue | 16 | Patient |
2023 | Endocarditis | 11 | Patient |
2023 | Dyspnea | 91 | Patient |
2023 | Dizziness | 7 | Patient |
2023 | Cough | 1 | Patient |
2023 | Confusion/ Disorientation | 1 | Patient |
2023 | Chills | 1 | Patient |
2023 | Chest Pain | 17 | Patient |
2023 | Cardiogenic Shock | 1 | Patient |
2023 | Thickening of Material | 1 | Device |
2023 | Perivalvular Leak | 6 | Device |
2023 | Patient-Device Incompatibility | 2 | Device |
2023 | Patient Device Interaction Problem | 11 | Device |
2023 | Microbial Contamination of Device | 3 | Device |
2023 | Insufficient Information | 116 | Device |
2023 | Inadequacy of Device Shape and/or Size | 1 | Device |
2023 | Gradient Increase | 129 | Device |
2023 | Fluid/Blood Leak | 36 | Device |
2023 | Difficult to Open or Close | 9 | Device |
2023 | Device Stenosis | 23 | Device |
2023 | Detachment of Device or Device Component | 3 | Device |
2023 | Degraded | 35 | Device |
2023 | Central Regurgitation | 3 | Device |
2023 | Calcified | 40 | Device |
2023 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
2022 | Syncope/Fainting | 1 | Patient |
2022 | Stroke/CVA | 1 | Patient |
2022 | Pulmonary Hypertension | 1 | Patient |
2022 | Insufficient Information | 20 | Patient |
2022 | Heart Failure/Congestive Heart Failure | 7 | Patient |
2022 | Fatigue | 2 | Patient |
2022 | Fall | 1 | Patient |
2022 | Endocarditis | 9 | Patient |
2022 | Dyspnea | 8 | Patient |
2022 | Dizziness | 1 | Patient |
2022 | Chest Pain | 3 | Patient |
2022 | Perivalvular Leak | 4 | Device |
2022 | Patient-Device Incompatibility | 2 | Device |
2022 | Patient Device Interaction Problem | 15 | Device |
2022 | Material Split, Cut or Torn | 2 | Device |
2022 | Material Perforation | 1 | Device |
2022 | Insufficient Information | 92 | Device |
2022 | Inadequacy of Device Shape and/or Size | 1 | Device |
2022 | Gradient Increase | 90 | Device |
2022 | Fluid/Blood Leak | 36 | Device |
2022 | Difficult to Open or Close | 13 | Device |
2022 | Detachment of Device or Device Component | 1 | Device |
2022 | Degraded | 26 | Device |
2022 | Calcified | 28 | Device |
2022 | Appropriate Term/Code Not Available | 1 | Device |
2022 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
2021 | Insufficient Information | 1 | Patient |
2021 | Dyspnea | 1 | Patient |
2021 | Perivalvular Leak | 1 | Device |
2021 | Patient Device Interaction Problem | 1 | Device |
2021 | Insufficient Information | 3 | Device |
2021 | Gradient Increase | 1 | Device |
2021 | Device Stenosis | 1 | Device |
2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
2020 | Insufficient Information | 1 | Patient |
2020 | Insufficient Information | 1 | Device |