Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015
Total Reports
153
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Delivery System Failure During Procedure
ultra, sheath, delivery, esheath, balloon
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Trends in Transfemoral Aortic Valve Implantation Related Thrombocytopenia.
Abu Khadija H, et al. · 2022
Multi-modality imaging for percutaneous pulmonary valve implantation - getting serious about radiation and contrast reduction.
Goreczny S, et al. · 2019
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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