Resolute Onyx™ RONYX45012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169557239), received between Jul 10, 2018 and Sep 12, 2022 — classified as 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT (DES)TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 70% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED RESOLUTE ONYX DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS DETAILED THAT IT WAS A TIGHT SPACE AND THE STENT MAY HAVE GOT CAUGHT ON THE PREVIOUSLY DEPLOYED STENT. AN NC EUPHORA DEVICE WAS ATTEMPTED TO BE USED TO APPOSE THE STENT WITHIN THE PREVIOUSLY DEPLOYED STENT WHERE THERE WAS SOME OVERLAP HOWEVER IT BECAME DISLODGED IN THE VESSEL WALL. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15400109 ↗
• InjuryAug 26, 2020Adverse 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 CX AND A NC EUPHORA PTA BALLOON CATHETER WAS ALSO USED IN THE CX. FOLLOWING DAY, PATIENT SUFFERED TROPONIN ELEVATION. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO THE DEVICE AND NOT RELATED TO ANTIPLATELET. CEC ADJUDICATED EVENT AS A NON-Q-WAVE MI OF THE TARGET VESSEL, MEDTRONIC EXTENDED HISTORICAL PERI-PCI. CEC ADJUDICATED STENT THROMBOSIS IN THE CX AS NON-EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 10452860 ↗
• InjuryAug 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE OSTIAL VEIN GRAFT. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. IT WAS ALSO REPORTED THAT THE STENT CAME OFF THE BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10367453 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX WAS IMPLANTED INTO THE LAD. ONE DAY POST INDEX PROCEDURE THE PATIENT SUFFERED PCI RELATED MI. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO ANTI-PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 8309627 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, FIVE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; FOUR IN THE LAD AND ONE IN THE 1ST DIAGONAL AND TWO NC EUPHORA BALLOONS WERE USED IN THE LAD. ON THE SAME DAY, PATIENT SUFFERED ELEVATED TROPONIN AND RECOVERED THE FOLLOWING DAY. CEC ADJUDICATED THE EVENT AS NON-Q WAVE MYOCARDIAL INFARCTION OF THE TARGET VESSEL. INVESTIGATOR ASSESSED THE EVENT IS UNLIKELY RELATED TO DEVICE AND NOT RELATED TO ANTIPLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 8150438 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, A RESOLUTE ONYX DES WAS IMPLANTED IN THE LAD, WHICH WAS REPORTED TO CAUSE PLAQUE SHIFT. A SECOND RESOLUTE ONYX DES WAS IMPLANTED IN THE LAD TO TREAT THE PLAQUE SHIFT.

  Patient problems: Occlusion

  MAUDE report 7994374 ↗
• MalfunctionJul 10, 2018Break; Detachment of Device or Device Component; Material Twisted/Bent; Physical Resistance/Sticking; Detachment of Device or Device Component

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION EXHIBITING 80% STENOSIS. IT WAS INFORMED THAT THE VESSEL ASSOCIATED WITH THE EVENT WAS LOCATED IN THE PROXIMAL RIGHT CAROTID. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE CATHETER SHAFT KINKED AND WAS UNABLE TO ADVANCE. THE DEVICE WAS RETURNED WITH A DETACHMENT ON THE SHAFT. IT WAS REPORTED THAT THE CATHETER BROKE IN THE BODY PRIOR TO STENT PLACEMENT. IT WAS REMOVED FROM THE BODY WITHOUT ANY COMPLICATIONS. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7672769 ↗