MOSAIC MITRAL BIOPROSTHETIC HEART VALVE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter)
Total Reports
780
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Post-Implant Complete Heart Block
pacemaker implanted, implanted reason, permanent, pacemaker reported, permanent pacemaker
8
reports
Explanted During Implant Procedure
medtronic received, replacement reported, explanted replaced, valve explanted, reason replacement
6
reports
Long-Term Evaluation for Replacement
mosaic aortic, medtronic received, reported medtronic, intervention, mosaic
3
reports
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
Comparative analysis of structural valve deterioration and long-term clinical outcomes after bovine pericardial versus porcine bioprosthetic mitral valve replacement
Woojung Kim, et al. · Journal of Thoracic Disease · 2021
Modes of the bioprosthetic valve failure of the porcine and pericardial valves in the mitral position
Gaku Uchino, et al. · European Journal of Cardio-Thoracic Surgery · 2021
One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve
Brian Whisenant, et al. · JAMA Cardiology · 2020
Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement
Matheus Simonato, et al. · Circulation · 2020
Transcatheter Mitral Valve-in-Valve Implantation with the Balloon-Expandable Myval Device
Sara Blasco‐Turrión, et al. · Journal of Clinical Medicine · 2022
Citations indexed from PubMed.
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