Onyx Frontier Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Coronary Drug-Eluting Stent · First cleared May 2022 · 73 device variants grouped
Total Reports
1,066
Reports (30d)
23
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Stent Dislodgment During Delivery
onyx frontier, delivery, coronary drug, frontier coronary, issues
50
reports
Balloon Retrieval Difficulty and Shaft Break
synergy, delivery, selected, shaft, synergy drug
4
reports
Residual Stenosis Post-Stent Treatment
residual stenosis, timi flow, synergy, aspirin, residual
3
reports
DAPT Duration Impact on Bleeding Risk
month, dapt, patients, bleeding, group
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
A technology evaluation of the Onyx Frontier drug-eluting stent
Pier Pasquale Leone, et al. · Expert Opinion on Drug Delivery · 2023
ELLIS Study: Comparative Analysis of Excimer Laser Coronary Angioplasty and Intravascular Lithotripsy on Drug-Eluting Stent as Assessed by Scanning Electron Microscopy
Borja Rivero Santana, et al. · Circulation Cardiovascular Interventions · 2024
Citations indexed from PubMed.
Keep exploring
Related devices in Coronary
Perclose ProGlide
ABBOTT VASCULAR INC. · 24,665 reports
Perclose ProStyle
ABBOTT VASCULAR INC. · 19,648 reports
PERCLOSE
ABBOTT VASCULAR INC. · 10,164 reports
SYNERGY
BOSTON SCIENTIFIC CORPORATION · 7,061 reports
Angio-Seal
TERUMO MEDICAL CORPORATION · 6,783 reports
Resolute Onyx
MEDTRONIC, INC. · 4,510 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
Get Early AccessUnderstanding this data