Onyx Frontier Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Coronary Drug-Eluting Stent · First cleared Apr 2017
Total Reports
309
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Dislodged Stent from Balloon
onyx frontier, coronary drug, frontier coronary, onyx, issues
15
reports
RV Lead High Impedance Detected
synergy, non bsc, bsc, shaft, advanced treatment
3
reports
RA Lead Dislodged and Replaced
synergy, residual stenosis, timi flow, aspirin, prior
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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