ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Oct 2020
Total Reports
852
Reports (30d)
15
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Edge Dissection Treated with New Stent
sierra stent, treat, dissection, delay, xience sierra
43
reports
Distal Edge Dissection After Implantation
significant delay, dissection adverse, xpedition, treat, dissection
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Evidence
Side-branch expansion capacity of contemporary DES platforms
Alper Öner, et al. · European journal of medical research · 2021
Comparison of overexpansion capabilities and thrombogenicity at the side branch ostia after implantation of four different drug eluting stents
Paweł Gąsior, et al. · Scientific Reports · 2020
Complex all-comers and patients with diabetes and prediabetes treated with Xience Sierra everolimus-eluting stents: COASTLINE high-risk.
van Vliet D, et al. · 2025
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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