Promus PREMIER Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared Nov 2013 · 94 device variants grouped
Total Reports
2,764
Reports (30d)
3
Active Signals
0
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
11
reports
Distal Edge Dissection After Deployment
synergy, stenosed target, edge dissection, stable, dissection occurred
3
reports
Residual Stenosis Post-Stent Treatment
residual stenosis, timi flow, synergy, aspirin, residual
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 Promus Premier everolimus-eluting platinum chromium stent with durable polymer evaluated in a real world all-comer population in Rotterdam cardiology hospital (the P-SEARCH registry).
Lemmert ME, et al. · International journal of cardiology · 2017
Occurrence and predictors of acute stent recoil-A comparison between the xience prime cobalt chromium stent and the promus premier platinum chromium stent.
van Bommel RJ, et al. · Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2017
Drug-Eluting-Balloon Angioplasty in Tunisian population versus Everolimus-platinum-chrome-stent for de-novo coronary lesion.
Nadhem Hajlaoui, et al. · PubMed · 2022
Stent deformation after surgical aortic valve replacement in a patient undergoing percutaneous coronary intervention of proximal right coronary artery
Takumi Osawa, et al. · European Heart Journal - Case Reports · 2023
Everolimus-Eluting Biodegradable Abluminal Coating Stent versus Durable Conformal Coating Stent: Termination of the Inflammatory Response Associated with Neointimal Healing in a Porcine Coronary Model
Masayuki Mori, et al. · Journal of Interventional Cardiology · 2020
Citations indexed from PubMed.
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