Promus ELITE Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared Nov 2011
Total Reports
953
Reports (30d)
9
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Cardiac Arrest Following Stent Deployment
cardiac, died, experienced, patients, pain
6
reports
Crossing Difficulties with Stent
difficulties, cross, atm, patients, encountered
5
reports
Proximal Edge Dissection During Deployment
stenosed target, cover, atm, edge dissection, dissection occurred
5
reports
In-Vivo Dislodgement During Delivery
onyx frontier, coronary drug, onyx, inspected, frontier
1
reports
Shaft Break During Lesion Crossing
stenosed target, shaft, advanced treatment, synergy drug, stent advanced
1
reports
Stent Dislodgement During Introduction
dislodgement occurred, patient complications, advanced treatment, synergy drug, stent advanced
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
Keep exploring
Related devices in Coronary
Perclose ProGlide
ABBOTT VASCULAR INC. · 24,591 reports
Perclose ProStyle
ABBOTT VASCULAR INC. · 19,487 reports
PERCLOSE
ABBOTT VASCULAR INC. · 10,006 reports
Angio-Seal
TERUMO MEDICAL CORPORATION · 6,574 reports
SYNERGY
BOSTON SCIENTIFIC CORPORATION · 6,056 reports
Resolute Onyx
MEDTRONIC, INC. · 4,478 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. 1 active signal detected right now.
Get Early AccessUnderstanding this data