Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
498
Reports (30d)
11
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Delivery System Failure During Procedure
ultra, sheath, delivery, esheath, balloon
27
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Transcatheter aortic valve replacement in low risk patients: a review of PARTNER 3 and Evolut low risk trials.
Braghiroli J, et al. · 2020
Long-Term Outcome of Covered Stent Implantation for Management of Iliofemoral Vascular Complications in Patients Undergoing Transcatheter Aortic Valve Replacement.
Johnson N, et al. · 2025
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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