16F X 36CM EDWARDS EXPANDABLE INTRODUCER SHEATH SET Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2014
Total Reports
276
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Registry Report: Cardiac Perforation Injuries
events, registry, injury, sapien ultra, thv
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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