EDWARDS SAPIEN TRANSCATHETER HEART VALVE (THV) Adverse Events: FDA MAUDE Data

Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared May 2012

Total Reports

335

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Death Following Tricuspid Surgery Post-ImplantEmerging

registry, implant sapien, sapien ultra, ultra resilia, ultra

reports

Balloon Rupture During Valve-in-Valve Procedure

ultra, clinical specialist, specialist, sapien ultra, resilia valve

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Evidence

Related research

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

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

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.