Promus ELITE Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared Nov 2011
Total Reports
957
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Cardiac Arrest After Stent Deployment
death, promus, synergy, experienced, patients
6
reports
RV Lead High Impedance Detected
synergy, non bsc, bsc, shaft, advanced treatment
5
reports
RA Lead Not Used Due to Unstable Thresholds
dissection occurred, promus, synergy, edge dissection, stable
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Less Is More: Developments in Nanotechnology for Antirestenosis Therapies
Chantal M. Trepanier, et al. · Arteriosclerosis Thrombosis and Vascular Biology · 2023
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 Gil, et al. · Biomedicines · 2024
Citations indexed from PubMed.
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