Promus ELITE Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared Sep 2018 · 47 device variants grouped
Total Reports
962
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Distal Edge Dissection After Deployment
synergy, stenosed target, edge dissection, stable, dissection occurred
2
reports
Balloon Retrieval Difficulty and Shaft Break
synergy, delivery, selected, shaft, synergy drug
1
reports
Cardiac Arrest Post-Procedure
death, synergy, cardiac, ivus, patients
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results
Robert Julian Gil, et al. · Biomedicines · 2024
Specific clinical vignettes in high-risk protected percutaneous coronary intervention
Vasileios F. Panoulas, et al. · European Heart Journal Supplements · 2022
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