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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

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MAUDE LookupStructural HeartMOSAIC MITRAL BIOPROSTHETIC HEART VALVE

MOSAIC MITRAL BIOPROSTHETIC HEART VALVE Adverse Events: FDA MAUDE Data

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

Total Reports

709

Reports (30d)

11

Active Signals

2

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Post-Implant Evaluation for Valve Replacement

adverse, effects, post implant, additional adverse, aortic bioprosthetic

21

reports

2

Permanent Pacemaker Due to Heart Block

pacemaker, implanted reason, effects, permanent, permanent pacemaker

19

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 reportinghighIncreasing trendmedium

Evidence

Related research

Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement

Matheus Simonato, et al. · Circulation · 2020

Heart team approach in treatment of mitral regurgitation: patient selection and outcome

Mischa Külling, et al. · Open Heart · 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.