XIENCE PRIME Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Oct 2012 · 10 device variants grouped
Total Reports
1,192
Reports (30d)
5
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Post-Market Clinical Evaluation Findings
evaluation report, polymer, clinical follow, market clinical, post market
4
reports
Balloon Retrieval Difficulty and Shaft Break
synergy, delivery, selected, shaft, synergy drug
1
reports
Proximal Edge Dissection During Implant
delay procedure, treat, provided procedure, procedure additional, significant delay
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
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
Impact of Intravascular Ultrasound–Guided Optimal Stent Expansion on 3-Year Hard Clinical Outcomes
Yong‐Joon Lee, et al. · Circulation Cardiovascular Interventions · 2021
Predicting Individual Treatment Effects to Determine Duration of Dual Antiplatelet Therapy After Stent Implantation
Seung‐Jun Lee, et al. · Journal of the American Heart Association · 2024
Citations indexed from PubMed.
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