Resolute Onyx™ RONYX45030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169557284), received between Mar 13, 2018 and Jun 8, 2020 — classified as 1 death, 1 injury, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathJun 8, 2020Adverse 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 2ND OBTUSE MARGINAL. TWO DAYS LATER DURING A STAGED PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED; TWO IN THE RAMUS AND ONE IN THE LCMA. APPROXIMATELY 20 MONTHS LATER, THE PATIENT SUFFERED CARDIOGENIC SHOCK, SEVERE MITRAL REGURGITATION, WORSENING RENAL FAILURE AND DIED. DEATH WAS CLASSIFIED AS NON SUDDEN CARDIAC DEATH. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10127337 ↗
• InjuryOct 31, 2019Adverse 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 RCA AND THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD DURING STAGED PROCEDURE. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM ATYPICAL CHEST PAIN . EVENT WAS TREATED WITH MEDICATION. CEC AND SAFETY ADJUDICATED THE EVENT AS NON-Q-WAVE MI, 3RD UDMI SPONTANEOUS (VESSEL UNKNOWN). INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9260149 ↗
• MalfunctionJan 7, 2019Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED ON THE RCA. 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 WHEN THE STENT EXITED THE GUIDE CATHETER IT WAS UNABLE TO CROSS THE LESION AND BECAME HUNG UP ON THE CALCIUM, THE STENT WAS REMOVED FROM THE PATIENT, UPON REMOVAL IT WAS OBSERVED THAT STENT DEFORMATION OCCURRED WITH A STRUT OF THE STENT BECOMING LIFTED. THE PROCEDURE WAS COMPLETED USING A SHORTER STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY IN RELATION TO THE RESOLUTE ONYX STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8221330 ↗
• MalfunctionMar 13, 2018Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND MODERATELY TORTUOUS LESION. IT WAS REPORTED THAT NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 AND NO EXCESSIVE FORCE USED. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE TARGET LESION. THE STENT FAILED TO CROSS AND WAS REMOVED. UPON REMOVAL OF THE STENT, THE GUIDE MOVED OUT OF THE LEFT MAIN AND THE PHYSICIAN TRIED TO PUT THE STENT BACK INTO THE GUIDE BUT THE STRUTS HAD BEEN DAMAGED WHEN IT RUBBED AGAINST THE GUIDE UPON INITIAL REMOVAL AND STRUTS WERE LIFTED. THE PHYSICIAN USED TWO SMALLER SIZED ONYX STENTS TO COMPLETE THE PROCEDURE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333339 ↗