EVOQUE Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Tricuspid Valve Replacement · First cleared Feb 2024
Total Reports
665
Reports (30d)
24
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Permanent Pacemaker on POD 0
right, days procedure, day procedure, vein permanent
55
reports
AV Block Post-Implant from Oversizing
wire, involving, post, ttvr, valve replacement
46
reports
Patient Expired 30 Days Post-Implant
patient expired, pod information, surgery intervention, tricuspid valve, expired pod
31
reports
Unplanned Cardiac Surgery 12 Days Post
surgery intervention, cardiac surgery, days procedure, intervention unplanned, unplanned days
20
reports
Permanent Pacemaker on POD 2
vein permanent
17
reports
Permanent Pacemaker on POD 1
vein permanent
14
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
Successful implantation of an EVOQUE-tricuspid valve replacement system in a patient with two right ventricular implantable cardioverter-defibrillator leads: a case report
Florian Genske, et al. · European Heart Journal - Case Reports · 2025
Transjugular Transcatheter Tricuspid Valve Replacement With the Evoque System
Tooba Salar, et al. · JACC Case Reports · 2025
Transcatheter Tricuspid Valve Replacement Reduces Heart Failure Hospitalization: Insights From the Canadian Evoque Registry
Alexandru Patrascu, et al. · Canadian Journal of Cardiology · 2026
Citations indexed from PubMed.
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