SAPIEN 3 Ultra System Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015 · 3 device variants grouped
Total Reports
955
Reports (30d)
4
Active Signals
3
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
33
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
In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve: the S3U registry.
Saia F, et al. · EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2020
Real-Time Fluoroscopic Assessment of Underexpansion Predicts Hemodynamic Valve Deterioration Following TAVR With Balloon-Expandable Device
Domenico Angellotti, et al. · JACC: Cardiovascular Interventions · 2025
Paravalvular leak after TAVR: remarkable improvement but not the time to shift focus
Dhruv Mahtta, et al. · Catheterization and Cardiovascular Interventions · 2021
Citations indexed from PubMed.
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