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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 Integrity

Resolute Integrity Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Coronary Drug-Eluting Stent · First cleared Feb 2012

Total Reports

1,762

Reports (30d)

7

Active Signals

1

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

18

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

Three contemporary thin‐strut drug‐eluting stents implanted in severely calcified coronary lesions of participants in a randomized all‐comers trial

Rosaly A. Buiten, et al. · Catheterization and Cardiovascular Interventions · 2020

Non-Inferiority of Resolute Integrity Drug-Eluting Stent to Benchmark Xience Drug-Eluting Stent.

Nakamura M, et al. · 2018

Three-year clinical outcomes between Endeavor Resolute® and Resolute Integrity® Zotarolimus-Eluting Stents in an Asian population

Yong Hoon Kim · The Anatolian Journal of Cardiology · 2020

Three-year clinical outcome of biodegradable hybrid polymer Orsiro sirolimus-eluting stent and the durable biocompatible polymer Resolute Integrity zotarolimus-eluting stent: A randomized controlled trial.

Kim SH, et al. · 2019

Comparison of the Major Clinical Outcomes for the Use of Endeavor® and Resolute Integrity® Zotarolimus-Eluting Stents During a Three-Year Follow-up.

Kim YH, et al. · 2020

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.