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

Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2014

Total Reports

1,362

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Balloon Rupture During Valve-in-Valve Procedure

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

reports

Valve Explantation After Long-Term Implant

implant patient, aortic position, registry, sapien ultra, explanted

reports

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

Evidence

Related research

One-year outcomes after transcatheter aortic valve implantation with the latest-generation SAPIEN balloon-expandable valve: the S3U registry

Stefano Cannata, et al. · EuroIntervention · 2023

Natural History of Leaflet Thrombosis After Transcatheter Aortic Valve Replacement: A 5‐Year Follow‐Up Study

Shohei Imaeda, et al. · Journal of the American Heart Association · 2022

Clinical Comparison of a Novel Balloon-Expandable Versus a Self-Expanding Transcatheter Heart Valve for the Treatment of Patients with Severe Aortic Valve Stenosis: The EVAL Registry

Monica Barki, et al. · Journal of Clinical Medicine · 2022

Determinants and Treatments of Heart Failure After Transcatheter Aortic Valve Implantation: Moving up a Notch

Kensuke Matsushita, et al. · ESC Heart Failure · 2023

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.