Resolute Onyx Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Coronary Drug-Eluting Stent · First cleared Apr 2017 · 140 device variants grouped
Total Reports
4,510
Reports (30d)
16
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Stent Deformation During Advancement
coronary drug, inspected, encountered advancing, advancing device, issues
7
reports
DAPT Duration Impact on Bleeding Risk
month, dapt, patients, bleeding, group
2
reports
Balloon Retrieval Difficulty and Shaft Break
synergy, delivery, selected, shaft, synergy drug
1
reports
Stent Dislodgment During Delivery
onyx frontier, delivery, coronary drug, frontier coronary, issues
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
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
Mynx Control
CORDIS CORPORATION · 2,959 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. 2 active signals detected right now.
Get Early AccessUnderstanding this data