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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 PREMIER

Promus PREMIER Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Coronary Drug-Eluting Stent · First cleared Nov 2011 · 94 device variants grouped

Total Reports

2,717

Reports (30d)

10

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 Flare Off Balloon Before Use

synergy, lesion located, shaft, completed, synergy drug

6

reports

3

Patient Death Following Stent Placement

synergy, cardiac, reference, lesion located, died

5

reports

4

Stent Crossing Failure in Tortuous Anatomy

located, procedure completed, stenosed target, encountered, completed

3

reports

5

In Vivo Stent Deformation During Advancement

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

2

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 Promus Premier everolimus-eluting platinum chromium stent with durable polymer evaluated in a real world all-comer population in Rotterdam cardiology hospital (the P-SEARCH registry).

Lemmert ME, et al. · 2017

Drug-Eluting-Balloon Angioplasty in Tunisian population versus Everolimus-platinum-chrome-stent for de-novo coronary lesion.

Nadhem Hajlaoui, et al. · PubMed · 2022

Mobilization of progenitor cells and vessel healing after implantation of SYNERGY in acute coronary syndrome.

Sakuma M, et al. · 2021

Occurrence and predictors of acute stent recoil-A comparison between the xience prime cobalt chromium stent and the promus premier platinum chromium stent.

van Bommel RJ, et al. · 2017

Assessment of Paclitaxel Drug-Coated Balloon-Only Angioplasty for Multivessel Coronary Artery Disease.

Merinopoulos I, et al. · 2025

Citations indexed from PubMed.

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Angio-Seal

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SYNERGY

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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.