MOSAIC PORCINE HEART VALVE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter)
Total Reports
175
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Evaluation for Valve-in-Valve Replacement
evaluated transcatheter, patient evaluated, reason evaluation, evaluation reported, replacement reason
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Comparison of Long-term Performance of Bioprosthetic Aortic Valves in Sweden From 2003 to 2018
Michael Persson, et al. · JAMA Network Open · 2022
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
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 · 13,973 reports
Evolut FX
MEDTRONIC, INC. · 13,543 reports
Evolut PRO
MEDTRONIC, INC. · 7,814 reports
CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS - AORTIC
Edwards Lifesciences LLC · 6,216 reports
CoreValve Evolut
MEDTRONIC, INC. · 4,459 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. 1 active signal detected right now.
Get Early AccessUnderstanding this data