Edwards EVOQUE Valve Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Tricuspid Valve Replacement · First cleared Feb 2024
Total Reports
104
Reports (30d)
61
Active Signals
2
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Post-Procedure Conduction Disturbance
vein, experienced, patient experienced, patient baseline, procedure post
22
reports
Complete AV Block After Valve Replacement
ttvr procedure, replacement ttvr, notification transcatheter, valve replacement, transcatheter tricuspid
21
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
Quality of Life After Transcatheter Tricuspid Valve Replacement
Suzanne V. Arnold, et al. · Journal of the American College of Cardiology · 2024
Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial
Philipp Lurz, et al. · European Heart Journal · 2025
Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study
Susheel Kodali, et al. · European Heart Journal · 2023
The Current Landscape of Transcatheter Tricuspid Valve Intervention
Henry Seligman, et al. · Journal of the Society for Cardiovascular Angiography & Interventions · 2023
Transjugular Transcatheter Tricuspid Valve Replacement
Lukas Stolz, et al. · JACC: Cardiovascular Interventions · 2024
Citations indexed from PubMed.
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