Avalus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Feb 2021
Total Reports
116
Reports (30d)
2
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Valve Explanted During Implant Procedure
adverse, medtronic received, effects, explanted replaced, valve explanted
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
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
Real-World Early Outcomes of the Avalus Aortic Valve: Results From 1250 Patients in the Avalus Clinical confidencE Registry
Lennart L.W. Vanglabeke, et al. · Annals of Thoracic Surgery Short Reports · 2026
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
Two-Year Results of the 17-mm Avalus Aortic Valve in the PERIGON Japan Trial
Yutaka Okita, et al. · Circulation Journal · 2021
Outcomes of Surgical Bioprosthetic Aortic Valve Replacement in Patients Aged ≤65 and >65 Years
Bob B. Kiaii, et al. · The Annals of Thoracic Surgery · 2022
Citations indexed from PubMed.
Keep exploring
Related devices in Structural
MitraClip
ABBOTT VASCULAR INC. · 18,874 reports
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve
Edwards Lifesciences LLC · 13,813 reports
Evolut FX
MEDTRONIC, INC. · 13,556 reports
Evolut PRO
MEDTRONIC, INC. · 7,814 reports
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC · 6,219 reports
WATCHMAN
BOSTON SCIENTIFIC CORPORATION · 4,722 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data