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SAPIEN 3 Ultra delivery system Adverse Events: FDA MAUDE Data

Edwards Lifesciences LLC · Transcatheter Aortic Valve (TAVR) · First cleared Jun 2015

Total Reports

348

Reports (30d)

0

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Evidence

Related research

Access site related vascular complications with third generation transcatheter heart valve systems

Hendrik Ruge, et al. · Catheterization and Cardiovascular Interventions · 2020

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.