NI Adverse Events: FDA MAUDE Data
EDWARDS LIFESCIENCES LLC · Replacement Heart Valve (Surgical/Transcatheter)
Total Reports
790
Reports (30d)
3
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Severe Stenosis After Long-Term Implant
condition, explanted implant, duration years, severe stenosis, explanted
6
reports
Evaluation for Valve Replacement Post-Implant
evaluated transcatheter, reason evaluation, patient evaluated, evaluation reported, replacement reason
2
reports
Evaluation for Transcatheter Replacement Post-Implant
mosaic aortic, medtronic received, reported medtronic, intervention, mosaic
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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