Resolute Onyx™ RONYX45022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169557260), received between Sep 28, 2017 and Jun 1, 2021 — classified as 1 death, 4 injuries.

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

• DeathJun 1, 2021Adverse 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 RCA. APPROXIMATELY 18 MONTHS POST PROCEDURE PATIENT SUFFERED KIDNEY FAILURE, PATIENT WAS PLACED ON HOSPICE AT HOME AND DIED ON THE SAME DAY. CEC ADJUDICATED THE EVENT AS CARDIAC DEATH.

  Patient problems: Renal Failure

  MAUDE report 11911504 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE CX. DURING A STAGED PROCEDURE, ONE RESOLUTE ONYX WAS IMPLANTED IN THE R-PDA. APPROXIMATELY 23 MONTHS POST INDEX PROCEDURE AND 22 MONTHS POST STAGED PROCEDURE, PATIENT SUFFERED FROM CHRONIC TOTAL ARTERY OCCLUSION. EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 11257250 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX STENT WAS IMPLANTED. ONE DAY POST INDEX PROCEDURE THE PATIENT SUFFERED A NON-Q WAVE MI. THE PATIENT WAS NOT TREATED WITH ANY MEDICAL INTERVENTION. THERE WAS NO IMPACT ON THE PATIENT. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO PRODUCT, THERAPY OR PROCEDURE. THE CEC ASSESSED THE EVENT AS NOT RELATED, TO PRODUCT, THERAPY OR PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 10447049 ↗
• InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, ONE RESOLUTE ONYX RX WAS IMPLANTED IN THE RCA. ON THE SAME DAY, PLAQUE PROLAPSE DURING STENT PROCEDURE WAS REPORTED IN THE TARGET VESSEL. THE PATIENT WAS TREATED WITH MEDICATION. THE INVESTIGATOR ASSESSED THE EVENT AS CASUALLY RELATED TO THE DEVICE AND NOT RELATED TO THE ANTIPLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 8105355 ↗
• InjurySep 28, 2017Burst Container or Vessel; Difficult or Delayed Positioning; Burst Container or Vessel; Difficult or Delayed Positioning

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS STENTS. THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES 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. INFLATION DIFFICULTIES WERE REPORTED AND THE BALLOON BURST DURING STENT DEPLOYMENT AFTER 6ATM OF PRESSURE WAS APPLIED. THE STENT WAS NOT FULLY EXPANDED AND WAS SUBSEQUENTLY DEPLOYED USING TWO NON-MDT BALLOONS. THE DEVICE WAS NOT MOVED OR RE-POSITIONED IN THE LESION PRIOR TO THE BURST. THE BURST OCCURRED ON THE FIRST INFLATION OF THE DEVICE AND THERE WAS A SUDDEN DROP IN PRESSURE. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS IMPLANTED AND REMAINS IN THE PATIENT. THE PATIENT IS ALIVE AND THERE IS NO PATIENT INJURY REPORTED POST PROCEDURE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6900617 ↗