EDWARDS CERTITUDE DELIVERY SYSTEM Adverse Events: FDA MAUDE Data

Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Dec 2016 · 8 device variants grouped

Total Reports

204

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Severe Stenosis and Heart Failure Symptoms

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

reports

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

Detection

Active safety signals

Disproportionate reportingmedium

Evidence

Related research

SCAI Expert Consensus Statement on Alternative Access for Transcatheter Aortic Valve Replacement

Matthew William Sherwood, et al. · Journal of the Society for Cardiovascular Angiography & Interventions · 2025

Review of alternative access in transcatheter aortic valve replacement

Adam Z. Banks, et al. · Cardiovascular Diagnosis and Therapy · 2020

Carotid versus femoral access for transcatheter aortic valve replacement: comparable results in the current era

Basile Marie, et al. · European Journal of Cardio-Thoracic Surgery · 2021

Trends in Transfemoral Aortic Valve Implantation Related Thrombocytopenia.

Abu Khadija H, et al. · Journal of clinical medicine · 2022

Early outcomes of transatrial mitral valve replacement in severe mitral annular calcification

Yuji Kawano, et al. · JTCVS Techniques · 2021

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.