EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE (THV) Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2014
Total Reports
1,371
Reports (30d)
6
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
12
reports
Valve Explantation Four Years Post-Implant
aortic position, registry, sapien ultra, months, explanted
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
Real-World Experience With the SAPIEN 3 Ultra Transcatheter Heart Valve: A Propensity-Matched Analysis From the United States
Tamim M. Nazif, et al. · Circulation Cardiovascular Interventions · 2021
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
One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry
Stefano Cannata, et al. · EuroIntervention · 2023
Deformation of Transcatheter Aortic Valve Prostheses: Implications for Hypoattenuating Leaflet Thickening and Clinical Outcomes
Miho Fukui, et al. · Circulation · 2022
Extremely Small 20-mm Versus Standard-Size Balloon-Expandable Transcatheter Heart Valves
Taishi Okuno, et al. · JACC Asia · 2024
Citations indexed from PubMed.
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