EVOQUE Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Tricuspid Valve Replacement · First cleared Feb 2024
Total Reports
757
Reports (30d)
0
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Conduction Disturbance One Week Post-Procedure
experienced, patient experienced, patient baseline, procedure post, iii
50
reports
Complete AV Block Post-Implant
ttvr procedure, tricuspid valve, notification transcatheter, valve replacement, transcatheter tricuspid
29
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Mar 27, 2026 · Open, Classified
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
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