CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

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