Mosaic Neo 310 Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Jul 2000 · 5 device variants grouped
Total Reports
3,838
Reports (30d)
54
Active Signals
4
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Severe Aortic Regurgitation Prompting Valve-in-Valve Replacement
evaluated transcatheter, reason evaluation, evaluation reported, adverse, effects
31
reports
Aortic Bioprosthesis Mixed Stenosis and Regurgitation
adverse, implanted valve, valve reason, effects, mosaic
24
reports
Valve-in-Valve Evaluation at Unknown Implant Duration
evaluated transcatheter, unknown duration, patient evaluated, reason evaluation, duration post
15
reports
Late Pacemaker Implant for Sick Sinus Syndrome
pacemaker, adverse, permanent, additional adverse, permanent pacemaker
12
reports
Valve-in-Valve Evaluation at Seven Years, Cause Unknown
evaluated transcatheter, patient evaluated, reason evaluation, replacement reason, information years
12
reports
Early Bioprosthesis Explant and Replacement, Cause Unknown
adverse, effects, replacement reported, additional adverse, explanted replaced
10
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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