CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
953
Reports (30d)
46
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Registry-Based Device Explant Notification
devices, patient registry, implant patient, registry, registry registry
13
reports
Severe Stenosis After Long-Term Implant
condition, explanted implant, duration years, severe stenosis, explanted
11
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Implanted size and structural valve deterioration in the Edwards Magna bioprosthesis
Douglas R. Johnston, et al. · Annals of Cardiothoracic Surgery · 2024
Eight‐year outcomes of aortic valve replacement with the Carpentier‐Edwards PERIMOUNT Magna Ease valve
Steven Tsui, et al. · Journal of Cardiac Surgery · 2022
Comparison of Long-term Performance of Bioprosthetic Aortic Valves in Sweden From 2003 to 2018
Michael Persson, et al. · JAMA Network Open · 2022
Early surgical aortic bioprosthesis failure caused by cusp tear: A word of caution
Thibault Schaeffer, et al. · Clinical Case Reports · 2020
Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry
Bart Meuris, et al. · Journal of Cardiothoracic Surgery · 2020
Citations indexed from PubMed.
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