Mosaic Neo 310 Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Replacement Heart Valve (Surgical/Transcatheter) · First cleared Jul 2000
Total Reports
3,733
Reports (30d)
0
Active Signals
2
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
29
reports
Long-Term Evaluation for Replacement
mosaic aortic, medtronic received, reported medtronic, intervention, mosaic
26
reports
Explanted During Implant Procedure
medtronic received, replacement reported, explanted replaced, valve explanted, reason replacement
9
reports
Post-Implant Complete Heart Block
pacemaker implanted, implanted reason, permanent, pacemaker reported, permanent pacemaker
9
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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