Edwards SAPIEN 3 Ultra Transcatheter Heart Valve Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Dec 2018 · 3 device variants grouped
Total Reports
13,813
Reports (30d)
194
Active Signals
2
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
339
reports
Valve Explantation Four Years Post-Implant
aortic position, registry, sapien ultra, months, explanted
88
reports
Literature Batch: Self-Expanding Valve Outcomes
devices, evolut, patients, study, included
6
reports
Death Post-Implant in Registry Data
registry, sapien ultra, resilia valve, ultra resilia, ultra
1
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
Valve-in-Surgical-Valve With SAPIEN 3 for Transcatheter Aortic Valve Replacement Based on Society of Thoracic Surgeons Predicted Risk of Mortality
Tsuyoshi Kaneko, et al. · Circulation Cardiovascular Interventions · 2021
Outcomes of transcatheter aortic valve replacement in patients with cardiogenic shock
Kashish Goel, et al. · European Heart Journal · 2023
Citations indexed from PubMed.
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