Resolute Onyx™ RONYX30018WRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169602519), received between Nov 13, 2017 and Apr 29, 2024 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 19199693 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD FIVE RESOLUTE ONYX CORONARY DRUG ELUTING STENTS IMPLANTED. IT WAS ALSO REPORTED THAT, APPROXIMATELY 14 MONTHS AFTER THE PROCEDURE, ONE STENT BECAME OCCLUDED AND WAS REPLACED BY A NON MEDTRONIC STENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 13257000 ↗
• MalfunctionOct 11, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT WAS DAMAGED. STENT STRUTS WERE FOUND TO BE STICKING OUT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7955569 ↗
• DeathMay 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE LAD. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED CEREBROVASCULAR ACCIDENT AND DIED (NON-CARDIAC). INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO STUDY DEVICE AND UNLIKELY RELATED TO ANTIPLATELET.

  Patient problems: Death; Stroke/CVA

  MAUDE report 7551994 ↗
• MalfunctionNov 13, 2017Leak/Splash; Leak/Splash

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RCA. THERE WAS NO DAMAGE NOTED TO PACKAGING AND THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT IS REPORTED THAT A BALLOON LEAK OCCURRED DURING NEGATIVE PREP PRIOR TO INFLATION. THE STENT WAS POSITIONED OVER THE LESION AND NOT MOVED/RE-POSITIONED PRIOR TO THE BALLOON LEAK. THE BALLOON LEAK OCCURRED IN THE PATIENT'S VESSEL. IT WAS REPORTED THAT NEGATIVE PREP OF THE DEVICE WAS DONE IN THE BODY AND WHEN THE TECH PULLED NEGATIVE WITH THE INDEFLATOR, WHEN THE STENT WAS IN THE ARTERY, BLOOD CAME BACK. IT IS UNKNOWN WHERE ON THE DEVICE THE LEAK OCCURRED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER ONYX DEVICE. NO PATIENT INJURY WAS REPORTED AND THE PATIENT IS CURRENTLY FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7023905 ↗