Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared May 2012
Total Reports
327
Reports (30d)
1
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Valve-in-Valve Procedure for Stenosis
ultra, clinical specialist, valve valve, field, field clinical
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Redo-Transcatheter Aortic Valve Implantation Using the SAPIEN 3/Ultra Transcatheter Heart Valves—Expert Consensus on Procedural Planning and Techniques
Giuseppe Tarantini, et al. · The American Journal of Cardiology · 2023
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
Transcatheter valve-in-valve implantation with the Edwards SAPIEN in patients with bioprosthetic heart valve failure: the Milan experience.
Latib A, et al. · 2012
Technique of transcatheter aortic valve implantation with the Edwards-Sapien heart valve using the transfemoral approach.
Cribier A, et al. · 2009
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. · 2012
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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