CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Jan 1996
Total Reports
1,159
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Template Summary: Registry Explant Notification
devices, patient registry, implant patient, registry, registry registry
4
reports
Explanted Valve After Extended Implant Duration
registry, explanted implant, implant duration, valve explanted, explanted
2
reports
Calcification-Induced Valve-in-Valve Procedure
procedure implant, valve procedure, implant duration, duration years, presented
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Carpentier-Edwards Magna Ease bioprosthesis: a multicentre clinical experience and 12-year durability
Antonio Piperata, et al. · European Journal of Cardio-Thoracic Surgery · 2021
Eight‐year outcomes of aortic valve replacement with the Carpentier‐Edwards PERIMOUNT Magna Ease valve
Steven S.L. Tsui, et al. · Journal of Cardiac Surgery · 2022
Valve-Related Outcomes up to Six Years of a Next-Generation Bovine Pericardial Bioprosthesis Compared with Its Predecessor: A Propensity-Matched Analysis
Alessandra Francica, et al. · Medical Sciences · 2026
Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis
Krzysztof Bartuś, et al. · European Journal of Cardio-Thoracic Surgery · 2020
Citations indexed from PubMed.
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