MOSAIC PORCINE HEART VALVE Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter)

Total Reports

173

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Permanent Pacemaker for Complete Heart Block

pacemaker, implanted reason, effects, permanent, permanent pacemaker

reports

Severe Aortic Regurgitation Post-Implant

transcatheter valve, adverse, valve valve, effects, transcatheter

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 reportinghigh

Evidence

Related research

Bovine pericardial versus porcine stented replacement mitral valves: early hemodynamic performance and clinical results of a randomized comparison of the Perimount and the Mosaic valves

Bo Fu, et al. · Journal of Thoracic Disease · 2021

Comparative analysis of structural valve deterioration and long-term clinical outcomes after bovine pericardial versus porcine bioprosthetic mitral valve replacement

Woojung Kim, et al. · Journal of Thoracic Disease · 2021

Modes of the bioprosthetic valve failure of the porcine and pericardial valves in the mitral position

Gaku Uchino, et al. · European Journal of Cardio-Thoracic Surgery · 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.