Edwards Lifesciences LLC · Transcatheter Tricuspid Valve Replacement · First cleared Feb 2024
Total Reports
641
Reports (30d)
25
Active Signals
2
Open Recalls
1
What the reports describe · Claripulse analysis
Permanent Pacemaker on Post-Op Day 0
right, day, day procedure
55
reports
Complete AV Block Post-Operative Day 1
post, replacement ttvr, notification transcatheter, valve replacement, transcatheter tricuspid
44
reports
Patient Expired Post-Operative Day 9
patient expired, pod information, surgery intervention, tricuspid valve, expired pod
41
reports
Permanent Pacemaker on Post-Op Day 2
26
reports
Unplanned Cardiac Intervention 12 Days Post-Op
surgery intervention, cardiac surgery, intervention unplanned, unplanned days, vein cardiac
19
reports
Permanent Pacemaker on Post-Op Day 1
14
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Mar 27, 2026 · Open, Classified
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
Evidence
Outcomes of Entrapped Right Ventricular Pacing or Defibrillator Leads Following Transcatheter Tricuspid Valve Replacement
Graham Peigh, et al. · JACC: Cardiovascular Interventions · 2025
Transjugular Transcatheter Tricuspid Valve Replacement With the Evoque System
Tooba Salar, et al. · JACC Case Reports · 2025
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
Transcatheter Tricuspid Valve Replacement Reduces Heart Failure Hospitalization: Insights from the Canadian Evoque Registry
Alexandru Patrascu, et al. · Canadian Journal of Cardiology · 2026
Tricuspid valve replacement outcomes by baseline tricuspid regurgitation severity: the TRISCEND II trial
Philipp Lurz, et al. · European Heart Journal · 2025
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.
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