Promus PREMIER Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared Nov 2011 · 94 device variants grouped
Total Reports
2,761
Reports (30d)
19
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
RV Lead High Impedance Detected
synergy, non bsc, bsc, shaft, advanced treatment
19
reports
RA Lead Not Used Due to Unstable Thresholds
dissection occurred, promus, synergy, edge dissection, stable
2
reports
Cardiac Arrest After Stent Deployment
death, promus, synergy, experienced, 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
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
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
Mobilization of progenitor cells and vessel healing after implantation of SYNERGY in acute coronary syndrome
Masashi Sakuma, et al. · Scientific Reports · 2021
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
Drug-Eluting-Balloon Angioplasty in Tunisian population versus Everolimus-platinum-chrome-stent for de-novo coronary lesion.
Nadhem Hajlaoui, et al. · PubMed · 2022
Citations indexed from PubMed.
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