ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Sep 2016
Total Reports
844
Reports (30d)
5
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Distal Edge Dissection After Implantation
significant delay, dissection adverse, xpedition, treat, dissection
14
reports
In Vivo Stent Deformation During Advancement
onyx frontier, procedure involving, coronary drug, onyx, frontier
1
reports
Stent Detachment During Preparation Process
sds, delay procedure, clinically, significant delay, delay
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Standardized bench test evaluation of coronary stents: Biomechanical characteristics.
Bonin M, et al. · 2018
Osstem Cardiotec Centum Stent Versus Xience Alpine Stent for De Novo Coronary Artery Lesion: A Multicenter, Randomized, Parallel-Designed, Single Blind Test.
Yoon CH, et al. · 2022
Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model.
Cho KH, et al. · 2021
Impact of everolimus-eluting stent length on long-term clinical outcomes of percutaneous coronary intervention.
Yano H, et al. · 2017
Comparison of coronary angioscopic findings 8 months after stent implantation between two kinds of biodegradable polymer-coated and one durable polymer-coated drug-eluting stent
Keisuke Yasumura, et al. · Coronary Artery Disease · 2020
Citations indexed from PubMed.
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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.
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