Resolute Onyx™ RONYX35012WRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169602588), received between Aug 21, 2018 and Apr 6, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2022Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED PRIOR TO STENT DEPLOYMENT. IT WAS STATED THAT THE REMOVAL DIFFICULTIES WERE DUE TO PATIENT MORPHOLOGY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021372 ↗
• MalfunctionJul 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX OTW CORONARY, DRUG ELUTING STENT WAS USED DURING A PROCEDURE TO TREAT A MODERATELY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE DILATED. IT IS INDICATED THAT THE DEVICE FAILED TO CROSS THE LESION FROM THE SVG TO OM. IT WAS REPORTED THAT THE STENT CAME OFF THE DEVICE OUTSIDE THE PATIENT BODY AFTER REMOVAL OF THE DEVICE FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263336 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE MID LAD. A SECOND RESOLUTE ONYX WAS ALSO IMPLANTED 6 MONTHS LATER. APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A CARDIAC ARREST IN THE LAD. THIS WAS TREATED WITH ONE DRUG ELUTING STENT . THE PATIENT RECOVERED. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE INDEX DEVICE OR ANTI PLATELET MEDICATION. SAFETY ASSESSMENT REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE, ANTIPLATELET MEDICATION OR PROCEDURE.

  Patient problems: Myocardial Infarction; Patient Problem/Medical Problem

  MAUDE report 7800363 ↗