NI Adverse Events: FDA MAUDE Data
EDWARDS LIFESCIENCES LLC · Replacement Heart Valve (Surgical/Transcatheter)
Total Reports
790
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Calcification-Induced Valve-in-Valve Procedure
procedure implant, valve procedure, implant duration, duration years, presented
2
reports
Degeneration Leading to Valve-in-Valve Replacement
mitral position, medical article, implanted mitral, position underwent, bioprosthesis
2
reports
Explanted Valve After Extended Implant Duration
registry, explanted implant, implant duration, valve explanted, 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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