SAPIEN 3 Ultra RESILIA Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Dec 2016 · 4 device variants grouped
Total Reports
4,016
Reports (30d)
118
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Severe Stenosis and Heart Failure Symptoms
ultra, specialist, sapien ultra, resilia valve, ultra resilia
230
reports
Valve Explantation Four Years Post-Implant
aortic position, registry, sapien ultra, months, explanted
22
reports
Death Post-Implant in Registry Data
registry, sapien ultra, resilia valve, ultra resilia, ultra
13
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
Acute Leaflet Dysfunction in Transcatheter Pulmonary Valves.
Qadir A, et al. · JACC. Case reports · 2026
Strategic Reintervention With Marked Oversizing and Overexpansion in TAV-in-SAV for Hemolytic Paravalvular Leak.
Saigan M, et al. · JACC. Case reports · 2026
One-year outcomes of the RESILIA balloon-expandable transcatheter valve: survival, hemodynamics, and hypoattenuated leaflet thickening.
Suruga K, et al. · Cardiovascular intervention and therapeutics · 2025
Double Inflation ("Double Tap") on Valve Expansion and Short-Term Outcomes After the Latest-Generation Balloon-Expandable TAVR.
Krishnamoorthy P, et al. · JACC. Cardiovascular interventions · 2025
Citations indexed from PubMed.
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