CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

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