XIENCE V Adverse Events: FDA MAUDE Data

ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared Aug 2011 · 30 device variants grouped

Total Reports

963

Reports (30d)

9

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

Most commonly reported problems

1

DAPT Duration Impact on Bleeding Risk

month, dapt, patients, bleeding, group

7

reports

2

Post-Market Clinical Evaluation Findings

evaluation report, polymer, clinical follow, market clinical, post market

4

reports

3

Proximal Edge Dissection During Implant

delay procedure, treat, provided procedure, procedure additional, significant delay

4

reports

4

Residual Stenosis Post-Stent Treatment

residual stenosis, timi flow, synergy, aspirin, residual

2

reports

5

Balloon Retrieval Difficulty and Shaft Break

synergy, delivery, selected, shaft, synergy drug

1

reports

6

Cardiac Arrest Post-Procedure

death, synergy, cardiac, ivus, patients

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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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.