SAPIEN 3 Ultra System Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
556
Reports (30d)
10
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Balloon Rupture During Valve-in-Valve Procedure
ultra, clinical specialist, specialist, sapien ultra, resilia valve
27
reports
Valve Explantation After Long-Term Implant
implant patient, aortic position, registry, sapien ultra, explanted
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Real-Time Fluoroscopic Assessment of Underexpansion Predicts Hemodynamic Valve Deterioration Following TAVR With Balloon-Expandable Device
Domenico Angellotti, et al. · JACC: Cardiovascular Interventions · 2025
Routine post-dilatation at nominal volume to optimise the expansion of balloon-expandable valves: the DOUBLE-TAP study
Ali Husain, et al. · EuroIntervention · 2025
In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra balloon-expandable transcatheter aortic valve: the S3U registry
Francesco Saia, et al. · EuroIntervention · 2020
Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry
Noriaki Moriyama, et al. · Catheterization and Cardiovascular Interventions · 2020
Paravalvular leak after TAVR: <i>remarkable improvement but not the time to shift focus</i>
Dhruv Mahtta, et al. · Catheterization and Cardiovascular Interventions · 2021
Citations indexed from PubMed.
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