Edwards EVOQUE Valve Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Tricuspid Valve Replacement · First cleared Feb 2024
Total Reports
771
Reports (30d)
20
Active Signals
2
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Valve-Release Asystole Requiring Pacing
notification evoque, received notification, edwards received, report received, pod
74
reports
Delayed High-Grade AV Block
germany patient, high degree, hospitalization medical, implantation performed, qrs
12
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.
Evidence
Related research
Real-World Outcomes of Transcatheter Tricuspid Valve Replacement
Raj Makkar, et al. · JAMA · 2026
Transcatheter tricuspid valve replacement—a comparison of clinical and procedural outcomes of two different prostheses
Florian Genske, et al. · Frontiers in Cardiovascular Medicine · 2026
Case series of transcatheter tricuspid EVOQUE valve implantation in Spain: clinical experience and early outcomes.
Pardo Sanz A, et al. · REC, interventional cardiology · 2025
Quality of Life After Transcatheter Tricuspid Valve Replacement
Suzanne V. Arnold, et al. · Journal of the American College of Cardiology · 2024
Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study
Susheel Kodali, et al. · European Heart Journal · 2023
Citations indexed from PubMed.
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