ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Aug 2011
Total Reports
924
Reports (30d)
12
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Stent Detachment During Preparation Process
sds, delay procedure, clinically, significant delay, delay
8
reports
In-Hospital Stent Thrombosis After Implant
thrombosis, article, patients, myocardial infarction, death
7
reports
In Vivo Stent Deformation During Advancement
onyx frontier, procedure involving, coronary drug, onyx, frontier
5
reports
Dislodged Stent from Delivery System
procedure treat, skypoint stent, skypoint, sds, xience skypoint
3
reports
Distal Edge Dissection After Implantation
significant delay, dissection adverse, xpedition, treat, dissection
3
reports
Patient Death Following Stent Placement
synergy, cardiac, reference, lesion located, died
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Device profile of the XIENCE V and XIENCE Sierra stents for the treatment of coronary artery disease: an overview of safety and efficacy.
Mitsis A, et al. · 2020
A clinical evaluation of the XIENCE V everolimus eluting stent in the treatment of patients with coronary artery disease: Result from Thailand Registry - XIENCE V performance evaluation (THRIVE study).
Kiatchoosakun S, et al. · 2016
Four-Year Outcomes of Multivessel Percutaneous Coronary Intervention With Xience V Everolimus-Eluting Stents.
Lee MS, et al. · 2019
Safety and Efficacy of Second-Generation Drug-Eluting Stents in Real-World Practice: Insights from the Multicenter Grand-DES Registry
You‐Jeong Ki, et al. · Journal of Interventional Cardiology · 2020
Long‐Term Clinical Outcomes of Biodegradable‐ Versus Durable‐Polymer‐Coated Everolimus‐Eluting Stents in Real‐World Post‐Marketing Study
Waiel Abusnina, et al. · Catheterization and Cardiovascular Interventions · 2024
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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