XIENCE Sierra Adverse Events: FDA MAUDE Data
ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Oct 2020 · 56 device variants grouped
Total Reports
2,045
Reports (30d)
8
Active Signals
0
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
16
reports
Post-Market Clinical Evaluation Findings
evaluation report, polymer, clinical follow, market clinical, post market
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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