LOTUS Edge Valve System Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Transcatheter Aortic Valve (TAVR) · First cleared Mar 2020
Total Reports
952
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Unspecified Death Months Post-Implant
months following, years months, following implant, tav, years
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Citations indexed from PubMed.
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