EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV) Adverse Events: FDA MAUDE Data
Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared May 2012
Total Reports
339
Reports (30d)
2
Active Signals
0
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
6
reports
Death Post-Implant in Registry Data
registry, sapien ultra, resilia valve, ultra resilia, ultra
1
reports
Deployment Issues with Delivery Catheter
deployment, dcs, catheter dcs, balloon, delivery catheter
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Ten year follow‐up of high‐risk patients treated during the early experience with transcatheter aortic valve replacement
Janarthanan Sathananthan, et al. · Catheterization and Cardiovascular Interventions · 2020
Acute and late outcomes of Transcatheter Aortic Valve Implantation (TAVI) for the treatment of severe symptomatic aortic stenosis in patients at high- and low-surgical risk.
Schymik G, et al. · Journal of interventional cardiology · 2012
Transcatheter valve-in-valve implantation with the Edwards SAPIEN in patients with bioprosthetic heart valve failure: the Milan experience.
Latib A, et al. · EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2012
Technique of transcatheter aortic valve implantation with the Edwards-Sapien heart valve using the transfemoral approach.
Cribier A, et al. · Herz · 2009
Transcatheter pulmonary valve implantation using the Edwards SAPIEN transcatheter heart valve.
Boone RH, et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2010
Citations indexed from PubMed.
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