CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Sep 1991
Total Reports
6,219
Reports (30d)
35
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
40
reports
Explanted Valve After Extended Implant Duration
registry, explanted implant, implant duration, valve explanted, explanted
10
reports
Template Summary: Patient Registry Tracking
devices, patient registry, implant patient, registry, patient device
10
reports
Calcification-Induced Valve-in-Valve Procedure
procedure implant, valve procedure, implant duration, duration years, presented
8
reports
Valve Explanted During Implant Procedure
adverse, medtronic received, effects, explanted replaced, valve explanted
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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