EDWARDS COMMANDER DELIVERY SYSTEM Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
2,587
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Balloon Rupture During Valve-in-Valve Procedure
ultra, clinical specialist, specialist, sapien ultra, resilia valve
38
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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