ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Oct 2012
Total Reports
1,177
Reports (30d)
4
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Distal Edge Dissection After Implantation
significant delay, dissection adverse, xpedition, treat, dissection
1
reports
In Vivo Stent Deformation During Advancement
onyx frontier, procedure involving, coronary drug, onyx, frontier
1
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
Impact of Intravascular Ultrasound–Guided Optimal Stent Expansion on 3-Year Hard Clinical Outcomes
Yong‐Joon Lee, et al. · Circulation Cardiovascular Interventions · 2021
Procedural Characteristics of Intravascular Ultrasound–Guided Percutaneous Coronary Intervention and Their Clinical Implications
Seung‐Yul Lee, et al. · Journal of the American Heart Association · 2022
Volumetric Stent Expansion Index to Assess Tapering Lesions Using Intravascular Ultrasound and Its Clinical Outcomes
Xi Wu, et al. · Reviews in Cardiovascular Medicine · 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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