EDWARDS ESHEATH INTRODUCER SET Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Oct 2019
Total Reports
727
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Valve-in-Valve Procedure for HALT
sapien ultra, resilia valve, resilia, ultra resilia, ultra
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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