SYNERGY Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared Oct 2015 · 108 device variants grouped
Total Reports
7,061
Reports (30d)
27
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Balloon Retrieval Difficulty and Shaft Break
synergy, delivery, selected, shaft, synergy drug
51
reports
Cardiac Arrest Post-Procedure
death, synergy, cardiac, ivus, patients
15
reports
Distal Edge Dissection After Deployment
synergy, stenosed target, edge dissection, stable, dissection occurred
9
reports
Residual Stenosis Post-Stent Treatment
residual stenosis, timi flow, synergy, aspirin, residual
7
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. · 24,665 reports
Perclose ProStyle
ABBOTT VASCULAR INC. · 19,648 reports
PERCLOSE
ABBOTT VASCULAR INC. · 10,164 reports
Angio-Seal
TERUMO MEDICAL CORPORATION · 6,783 reports
Resolute Onyx
MEDTRONIC, INC. · 4,510 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. 1 active signal detected right now.
Get Early AccessUnderstanding this data