CARPENTIER-EDWARDS BIOPROSTHESIS - AORTIC Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
786
Reports (30d)
1
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
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Thoracic endovascular aortic repair for iatrogenic descending aortic pseudoaneurysm after aborted transcatheter aortic valve implantation
Federico Bargagna, et al. · Journal of Vascular Surgery Cases and Innovative Techniques · 2026
Five‐year outcomes of rapid‐deployment aortic valve replacement with the Edwards Intuity valve
Edeline Pelcé, et al. · Journal of Cardiac Surgery · 2021
Citations indexed from PubMed.
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