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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 InterventionResolute Onyx

Resolute Onyx Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Coronary Drug-Eluting Stent · First cleared Apr 2017 · 139 device variants grouped

Total Reports

4,467

Reports (30d)

8

Active Signals

2

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

In Vivo Stent Deformation During Advancement

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

11

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 reportinghighDisproportionate reportinghigh

Evidence

Related research

Use of drug-eluting, balloon-expandable resolute onyx coronary stent as a novel treatment strategy for vertebral artery ostial stenosis: Case series

Jaims Lim, et al. · Interventional Neuroradiology · 2022

Short dual antiplatelet therapy after PCI with Resolute Onyx drug-eluting stents in high bleeding risk patients: One-year outcomes from a South Asian cohort.

Jariwala P, et al. · 2025

Use of Onyx Frontier™ for intracranial stenting in stroke patients: A multicenter retrospective study.

Chahine A, et al. · 2024

Sex-Based Outcomes in Patients With High Bleeding Risk After PCI With 1-Month DAPT: Results From the Onyx ONE Clear Study.

Mehran R, et al. · 2026

Amphilimus-eluting versus zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: extended follow-up of the SUGAR randomised controlled trial.

Salinas P, et al. · 2025

Citations indexed from PubMed.

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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 2 active signals detected right now.

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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.