Resolute Onyx™ RONYX50012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169557291), received between Jan 31, 2018 and Nov 6, 2020 — classified as 2 deaths, 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE FOUR RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 26 MONTHS LATER THE PATIENT SUFFERED NON-TARGET VESSEL MYOCARDIAL INFARCTION. THE PATIENT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE. CEC ADJUDICATED THE EVENT AS MI (VESSEL UNKNOWN)

  Patient problems: Myocardial Infarction

  MAUDE report 10800857 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE FOUR RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 26 MONTHS LATER THE PATIENT SUFFERED NON-TARGET VESSEL MYOCARDIAL INFARCTION. THE PATIENT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE. CEC ADJUDICATED THE EVENT AS MI (VESSEL UNKNOWN)

  Patient problems: Myocardial Infarction

  MAUDE report 10800725 ↗
• InjuryJul 23, 2020Adverse 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 30 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION (UNKNOWN VESSEL). EVENT WAS TREATED WITH MULTIPLE STENTS IMPLANTED AND MEDICATION. INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE AND UNLIKELY RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Injury; Myocardial Infarction

  MAUDE report 10313095 ↗
• DeathMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, FOUR RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE RCA. SEVEN MEDTRONIC PTA BALLOONS WERE ALSO USED DURING PROCEDURE. APPROXIMATELY 32 MONTHS POST PROCEDURE, PATIENT SUFFERED UNSTABLE ANGINA WITH KNOWN CORONARY ARTERY DISEASE AND WAS TREATED WITH CHANGE IN MEDICATION. A MONTH LATER, PATIENT EXPIRED. DEATH IS OF UNKNOWN CLASSIFICATION. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10074199 ↗
• 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 9260189 ↗
• InjuryJun 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS INTENDED TO BE USED TO TREAT A RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO THE LESION. THE STENT WAS LOCATED IN THE SUBLCLAVIAN AND SNARED BACK TO THE AXILLARY ARTERY AND DEPLOYED. IT WAS NOTED THAT THERE WAS A LOT OF CARDIAC MOTION WHILE DEPLOYING THE STENT AND RCA TAKEOFF WAS NOT NORMAL. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Injury

  MAUDE report 8721783 ↗
• DeathJun 14, 2019Adverse 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 LCMA. APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE THE PATIENT DIED A NON CARDIAC DEATH. IT WAS REPORTED THAT DEATH WAS LIKELY TO DUE TO RESPIRATORY FAILURE AS THERE WERE HYPOXIC LUNG OPACITIES ON IMAGING. THE INVESTIGATOR REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE OR ANTI PLATELETS.

  Patient problems: Death

  MAUDE report 8699129 ↗
• MalfunctionJun 12, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A EUPHORA RX PTCA BALLOON CATHETER, AN NC EUPHORA RX PTCA BALLOON CATHETER, AND A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON TORTUOUS, SEVERELY CALCIFIED LESION IN OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED USING A CUTTING BALLOON. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED DURING DELIVERY OF THE NC EUPHORA AND THE RESOLUTE ONYX DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF ALL THREE DEVICES. IT WAS REPORTED THAT ALL THREE DEVICES BURST WHEN INFLATED TO 12 ATM. THE RESOLUTE ONYX BURST DURING STENT DEPLOYMENT. ONE INFLATION HAD BEEN APPLIED TO THE RESOLUTE ONYX PRIOR TO THE BURST. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8690543 ↗
• MalfunctionJan 21, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  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 LOCATED IN THE OSTIUM LEFT MAIN WITH 95% STENOSIS. THE LESION WAS NOTED TO HAVE A SHARP ANGLE. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE DILATED WITH A 2.0 X 12MM COMPLIANT BALLOON AND THEN A 3.0 X 12 NC BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT DISLODGED IN VIVO DURING A FAILED DELIVERY. AN ATTEMPT WAS MADE TO DELIVER THE STENT BUT WAS UNSUCCESSFUL. THE STENT WAS REMOVED FROM THE BODY. PRE DILATION WAS PERFORMED AGAIN USING A 4.0 X 12MM NC BALLOON AND THE LESION WAS CROSSED WITH A 6F GUIDELINER. THE STENT WAS INSPECTED FOR ANY REMOVAL DAMAGE AND NO DAMAGE WAS NOTED. THE STENT WAS THEN DELIVERED THROUGH THE GUIDELINER INTO THE LESION. AFTER RETRACTING THE GUIDELINER BACK INTO THE GUIDE IN ORDER TO PULL BACK THE STENT INTO A BETTER DEPLOYMENT POSITION, THE STENT CAME BACK TOO FAR AND WENT BACK INTO THE GUIDELINER AND GUIDE. AN ATTEMPT WAS MAD

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8263934 ↗
• InjuryJan 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. ON THE SAME DAY, PCI RELATED MI WAS REPORTED. NO ACTION WAS TAKEN. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE ANTI-PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 8216276 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX, ONE RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED IN THE GRAFT R-PDA. APPROXIMATELY ONE MONTH LATER ACUTE DI VERTICULITIS WAS REPORTED. PATIENT HAD BLOODY STOOLS AND WAS GIVEN ANTIBIOTICS. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO DEVICE AND DRUG.

  Patient problems: Blood Loss

  MAUDE report 8188836 ↗
• MalfunctionSep 13, 2018Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION IN THE MID LAD WITH MODERATE TORTUOSITY, SEVERE CALCIFICATION AND EXHIBITING 100% STENOSIS (CTO). THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. NO DAMAGE WAS NOTED TO PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE HOOP/TRAY. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. A GUIDELINER WAS USED WHEN DELIVERING THE DEVICE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT COMPLETELY DISLODGED AND CRUMPLED. THE PHYSICIAN FELT THE STENTGOT STUCK AND PULLED OUT THE WHOLE SYSTEM WITH THE MANGLED STENT WITHIN THE GUIDELINER. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT ALONG WITH THE GUIDELINER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7872067 ↗
• InjuryJan 31, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  DURING THE PROCEDURE A RESOLUTE ONYX RX DRUG ELUTING STENT WAS DEPLOYED IN THE RCA, AT 12 ATM. IT WAS REPORTED THAT THE STENT EMBOLIZED INTO THE GUIDE CATHETER. THE GUIDE WAS RETRACTED HOWEVER, THE STENT REMAINED IN THE RIGHT SUBCLAVIAN. THE STENT WAS SNARED AND PULLED BACK INTO THE GUIDE CATHETER AND REMOVED FROM THE BODY INTACT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7230397 ↗