Avalus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Feb 2021
Total Reports
114
Reports (30d)
7
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Device Explant Without Replacement Reason
medtronic received, replacement reported, explanted replaced, valve explanted, reason replacement
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial
Yutaka Okita, et al. · Circulation Journal · 2021
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
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
Early and Midterm Outcomes of INSPIRIS RESILIA Versus AVALUS: A Propensity Score Matching Analysis
Takuya Narita, et al. · Heart Lung and Circulation · 2025
Citations indexed from PubMed.
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