Edwards EVOQUE Valve Adverse Events: FDA MAUDE Data

Edwards Lifesciences LLC · Transcatheter Tricuspid Valve Replacement · First cleared Feb 2024

Total Reports

593

Reports (30d)

225

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Permanent Pacemaker on POD 0Emerging

right, days, days procedure, vein permanent

reports

Unplanned Cardiac Intervention 12 Days PostEmerging

surgery intervention, days procedure, intervention unplanned, unplanned days, vein cardiac

reports

Unplanned Surgery with Patient Expiration POD 9Emerging

patient expired, pod information, surgery intervention, unplanned, expired pod

reports

Permanent Pacemaker on POD 2Emerging

vein permanent

reports

Permanent Pacemaker on POD 1Emerging

vein permanent

reports

Permanent Pacemaker on POD 6Emerging

vein permanent

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 reportinghighVolume spikecritical

Evidence

Related research

Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study

Susheel Kodali, et al. · European Heart Journal · 2023

Quality of Life After Transcatheter Tricuspid Valve Replacement

Suzanne V. Arnold, et al. · Journal of the American College of Cardiology · 2024

Residual Tricuspid Regurgitation After Tricuspid Transcatheter Edge-to-Edge Repair: Insights Into the EuroTR Registry

Lukas Stolz, et al. · European Journal of Heart Failure · 2024

Transjugular Transcatheter Tricuspid Valve Replacement

Lukas Stolz, et al. · JACC: Cardiovascular Interventions · 2024

Transcatheter treatment for tricuspid valve disease

Fabien Praz, et al. · EuroIntervention · 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.