XIENCE Skypoint Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared May 2025
Total Reports
308
Reports (30d)
20
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Distal Edge Dissection Post-Implant
additional information, information provided, skypoint, xience skypoint, provided procedure
32
reports
Polymer-Free Stent Safety Outcomes
outcomes, polymer, article, patients, years
1
reports
RV Lead High Impedance Detected
synergy, non bsc, bsc, shaft, advanced treatment
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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