EDWARDS COMMANDER DELIVERY SYSTEM Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015 · 4 device variants grouped
Total Reports
2,922
Reports (30d)
53
Active Signals
4
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
88
reports
Death Post-Implant in Registry Data
registry, sapien ultra, resilia valve, ultra resilia, ultra
2
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
Balloon Dilatation of Expandable Sheath to Facilitate Transfemoral SAPIEN 3 Transcatheter Aortic Valve Replacement in Severely Calcified Vasculature
Maheedhar Gedela, et al. · Journal of the Society for Cardiovascular Angiography & Interventions · 2022
4-Dimensional Intracardiac Echocardiography-Guided Antegrade TAVR Using a Novel CABLE-TAVR Technique
Kaleb J. Robin, et al. · JACC Case Reports · 2026
Gutter Rotation Technique for Percutaneous Ipsilateral Retrieval of a Ruptured SAPIEN‐3 Balloon
Anne Venkata Ganeshkumar, et al. · Catheterization and Cardiovascular Interventions · 2026
Citations indexed from PubMed.
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