XIENCE Skypoint Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared May 2025 · 73 device variants grouped
Total Reports
1,610
Reports (30d)
42
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Proximal Edge Dissection During Implant
delay procedure, treat, provided procedure, procedure additional, significant delay
57
reports
Cardiac Arrest Post-Procedure
death, synergy, cardiac, ivus, patients
5
reports
DAPT Duration Impact on Bleeding Risk
month, dapt, patients, bleeding, group
2
reports
Post-Market Clinical Evaluation Findings
evaluation report, polymer, clinical follow, market clinical, post market
2
reports
Balloon Retrieval Difficulty and Shaft Break
synergy, delivery, selected, shaft, synergy drug
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Second-generation everolimus-eluting intracoronary stents: a comprehensive review of the clinical evidence
Ridhima Goel, et al. · Future Cardiology · 2024
One-year Outcomes of XIENCE Skypoint 48-mm Drug-Eluting Stents in Long Coronary Lesions: The SPIRIT 48 Trial
Ki E. Park, et al. · Journal of the Society for Cardiovascular Angiography & Interventions · 2023
Citations indexed from PubMed.
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