SAPIEN 3 Ultra RESILIA Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
385
Reports (30d)
108
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Death Following Tricuspid Surgery Post-ImplantEmerging
registry, implant sapien, sapien ultra, ultra resilia, ultra
8
reports
Balloon Rupture During Valve-in-Valve Procedure
ultra, clinical specialist, specialist, sapien ultra, resilia valve
63
reports
Valve Explantation After Long-Term Implant
implant patient, aortic position, registry, sapien ultra, explanted
6
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Improved hemodynamic performance and reduced paravalvular regurgitation with the SAPIEN 3 Ultra RESILIA valve: a propensity-matched single-center TAVR study
Meha Krishnareddigari, et al. · Frontiers in Cardiovascular Medicine · 2026
A stuck leaflet after balloon post-dilatation in transcatheter aortic valve implantation with a SAPIEN-3 ultra RESILIA valve: a case report
Shinji Yamazoe, et al. · European Heart Journal - Case Reports · 2024
Strategic Reintervention With Marked Oversizing and Overexpansion in TAV-in-SAV for Hemolytic Paravalvular Leak
Makoto Saigan, et al. · JACC Case Reports · 2026
1-Year Real-World Outcomes of TAVR With the Fifth-Generation Balloon-Expandable Valve in the United States
Annapoorna Kini, et al. · JACC: Cardiovascular Interventions · 2024
Performance and outcomes of the SAPIEN 3 Ultra RESILIA transcatheter heart valve in the OCEAN-TAVI registry
Masanori Yamamoto, et al. · EuroIntervention · 2024
Citations indexed from PubMed.
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