Resolute Onyx™ RONYX27515WRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169602410), received between Dec 15, 2017 and Apr 28, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE CIRCUMFLEX (CX). ONE SPRINTER BALLOON WAS ALSO USED DURING THE PROCEDURE. APPROXIMATELY 24 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM IN-STENT RESTENOSIS AND OCCLUSION IN THE CIRCUMFLEX STENT. THE EVENT WAS TREATED WITH MEDICAL MANAGEMENT, RISK FACTOR MODIFICATION AND MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14235346 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE CX. ONE SPRINTER BALLOON WAS ALSO USED DURING THE PROCEDURE. APPROXIMATELY 24 MONTHS POST PROCEDURE THE PATIENT SUFFERED FROM NON ST ELEVATED MYOCARDIAL INFARCTION IN THE LCX (TARGET VESSEL). THE EVENT WAS TREATED WITH MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 13024063 ↗
• MalfunctionFeb 7, 2018Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID LAD. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE PHYSICIAN WAS TRYING TO PASS THE RESOLUTE ONYX STENT THROUGH EXISTING OLDER UNKNOWN BRAND STENT, AND IT GOT CAUGHT ON THE PREVIOUSLY PLACED STENT. THE DEVICE FAILED TO CROSS THE LESION. IT WAS REPORTED THAT THE STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A MEDTRONIC PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7246909 ↗
• InjuryDec 15, 2017Material Distortion; Material Distortion

  THE PATIENT PRESENTED WITH AN ACUTE ST-ELEVATED ANTEROLATERAL WALL MYOCARDIAL INFRACTION. A 2.75 X15 MM RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN A MILDLY CALCIFIED, MILDLY TORTUOUS, TOTALLY OCCLUDED LESION EXHIBITING 100% STENOSIS IN THE PROXIMAL LAD WITHOUT ANY REPORTED ISSUE. DEVICE HAD BEEN INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT, NO RESISTANCE WAS ENCOUNTERED AND NO EXCESSIVE FORCE USED DURING DELIVERY. THE LESION HAD BEEN PREDILATED. INTRACORONARY NITROGLYCERIN AND VERAPAMIL WERE ADMINISTERED. BRILINTA AND ASPIRIN WERE ALSO ADMINISTERED. THERE WAS NO ABNORMALITY REPORTED IN RELATION TO THE ANATOMY. IT IS REPORTED THAT THE FOLLOWING DAY THE PATIENT PRESENTED WITH CHEST PAIN AND ST ELEVATION; THROMBOSIS WAS FOUND IN THE MID-DISTAL STENT. THE PATIENT WAS ANTICOAGULATED WITH HEPARIN. AN EXPORT CATHETER WAS USED WITH EXCELLENT RESULTS; BALLOON ANGIOPLASTY WAS CARRIED OUT WITH A 3.0 X 12 NC EUPHORA. NO SIGNIFICANT DISSECTION WAS FOUND BUT THERE APPEARED TO BE DYE HANG UP DISTAL TO THE STENT. A 3 X15 MM RESOLUTE ONYX WAS PLACED IN THE DISTAL LAD AND POST DILATION WAS CARRIED OUT USING A 3 X12 NC EUPHORA TO 24 ATMOSPHERES. T

  Patient problems: Angina; Intimal Dissection; Thrombus

  MAUDE report 7121610 ↗