CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS - AORTIC Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
1,681
Reports (30d)
9
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Aortic Valve Explant at Nearly Eight Years, Cause Unknown
devices, patient registry, implant patient, registry, registry registry
9
reports
Aortic Valve Explant at Seven Years, Cause Unknown
registry, explanted implant, implant duration, duration years, explanted
3
reports
Aortic Bioprosthesis Degeneration with Stenosis
article, position underwent, surgical, underwent valve, underwent
1
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
Different Rates of Bioprosthetic Aortic Valve Failure With Perimount™ and Trifecta™ Bioprostheses
Rüdiger Lange, et al. · Frontiers in Cardiovascular Medicine · 2022
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
Carpentier-Edwards Magna Ease bioprosthesis: a multicentre clinical experience and 12-year durability
Antonio Piperata, et al. · European Journal of Cardio-Thoracic Surgery · 2021
Comparison of Long-term Performance of Bioprosthetic Aortic Valves in Sweden From 2003 to 2018
Michael Persson, et al. · JAMA Network Open · 2022
Ten-year reintervention-free survival after surgical aortic valve replacement for different prosthetic aortic valve models: comparison using real-world data from the Netherlands Heart Registration
Hector W.L. de Beaufort, et al. · Interdisciplinary CardioVascular and Thoracic Surgery · 2026
Citations indexed from PubMed.
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