XIENCE PRIME Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Oct 2012
Total Reports
1,183
Reports (30d)
5
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Delivery System Balloon Deflation Failure
skypoint, xience skypoint, significant delay, delay, procedure additional
6
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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