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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Coronary Intervention
MAUDE LookupCoronary InterventionXIENCE Skypoint

XIENCE Skypoint Adverse Events: FDA MAUDE Data

ABBOTT VASCULAR INC. · Coronary Drug-Eluting Stent · First cleared May 2025

Total Reports

236

Reports (30d)

12

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Dislodged Stent from Delivery System

procedure treat, skypoint stent, skypoint, sds, xience skypoint

14

reports

2

Stent Detachment During Preparation Process

sds, delay procedure, clinically, significant delay, delay

2

reports

3

Patient Death Following Stent Placement

synergy, cardiac, reference, lesion located, died

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

Disproportionate reportinghigh

Evidence

Related research

One-year Outcomes of XIENCE Skypoint 48-mm Drug-Eluting Stents in Long Coronary Lesions: The SPIRIT 48 Trial.

Park KE, et al. · 2023

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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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.