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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 InterventionPromus ELITE

Promus ELITE Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared Nov 2011

Total Reports

940

Reports (30d)

8

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Proximal Edge Dissection Post-Deployment

dissection, dissection occurred, located, synergy, lesion located

6

reports

2

Stent Crossing Failure in Tortuous Anatomy

located, procedure completed, stenosed target, encountered, completed

5

reports

3

In Vivo Stent Deformation During Advancement

onyx frontier, procedure involving, coronary drug, onyx, frontier

1

reports

4

Stent Flare Off Balloon Before Use

synergy, lesion located, shaft, completed, synergy drug

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

The Vanishing Stent: A Rare Case Report of an Extracardiac Migration of a Coronary Stent.

Bhastana VJ, et al. · 2025

The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results

Robert Gil, et al. · Biomedicines · 2024

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.