Resolute Onyx Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Coronary Drug-Eluting Stent · First cleared Apr 2017 · 140 device variants grouped

Total Reports

4,494

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Device Resistance During Delivery

coronary drug, issues, negative prep, prep, device inspected

reports

Dislodged Stent from Balloon

onyx frontier, coronary drug, frontier coronary, onyx, issues

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Evidence

Related research

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

Pankaj Jariwala, et al. · American Heart Journal Plus Cardiology Research and Practice · 2025

First Report of 3-Year Clinical Outcome After Treatment With Novel Resolute Onyx Stents in the Randomized BIONYX Trial

Eline H. Ploumen, et al. · Circulation Journal · 2021

Device profile of the Resolute Onyx Zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy

Moritz Blum, et al. · Expert Review of Medical Devices · 2020

Rationale and design of INFINITY-SWEDEHEART: A registry-based randomized clinical trial comparing clinical outcomes of the sirolimus-eluting DynamX bioadaptor to the zotarolimus-eluting Resolute Onyx stent

David Erlinge, et al. · American Heart Journal · 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.