Avalus Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Feb 2021

Total Reports

101

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Adverse Effects Following Valve Explant

adverse, medtronic received, reported medtronic, effects, additional adverse

reports

Permanent Pacemaker Implant for Heart Block

pacemaker, implanted reason, permanent, pacemaker reported, permanent pacemaker

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

Surgical aortic valve replacement with a stented pericardial bioprosthesis: 5-year outcomes

Robert J.M. Klautz, et al. · European Journal of Cardio-Thoracic Surgery · 2022

Seven-year outcomes after surgical aortic valve replacement with a stented bovine pericardial bioprosthesis in over 1100 patients: a prospective multicentre analysis

Joseph F. Sabik, et al. · European Journal of Cardio-Thoracic Surgery · 2024

Comparison of safety and haemodynamic performance between the Avalus™ stented aortic valve bioprosthesis and Magna™ valve in Japanese patients

Naoki Tadokoro, et al. · General Thoracic and Cardiovascular Surgery · 2021

Early and Midterm Outcomes of INSPIRIS RESILIA Versus AVALUS: A Propensity Score Matching Analysis

Takuya Narita, et al. · Heart Lung and Circulation · 2025

Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial

Yutaka Okita, et al. · Circulation Journal · 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.