MOSAIC MITRAL BIOPROSTHETIC HEART VALVE Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Jul 2000
Total Reports
822
Reports (30d)
18
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Early Bioprosthesis Explant and Replacement, Cause Unknown
adverse, effects, replacement reported, additional adverse, explanted replaced
18
reports
Late Pacemaker Implant for Sick Sinus Syndrome
pacemaker, adverse, permanent, additional adverse, permanent pacemaker
10
reports
Severe Aortic Regurgitation Prompting Valve-in-Valve Replacement
evaluated transcatheter, reason evaluation, evaluation reported, adverse, effects
2
reports
Valve-in-Valve Evaluation at Seven Years, Cause Unknown
evaluated transcatheter, patient evaluated, reason evaluation, replacement reason, information years
2
reports
Aortic Bioprosthesis Mixed Stenosis and Regurgitation
adverse, implanted valve, valve reason, effects, mosaic
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
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
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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