Resolute Onyx™ RONYX27534UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169556942), received between Dec 18, 2017 and Jun 1, 2022 — classified as 1 death, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 1, 2022Burst Container or Vessel; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Burst Container or Vessel; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX 2.75 X 34MM CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED. DIFFICULTY WAS ENCOUNTERED WITH DELIVERABILITY TO THE DISTAL RIGHT CORONARY ARTERY. THE SEQUENCE OF THE PROCEDURE IS AS FOLLOWS. A 6F GUIDE CATHETER WAS INTRODUCED, ADVANCED, AND REMOVED. A 0.014X180CM RUN-THROUGH GUIDEWIRE WAS ADVANCED ACROSS THE RIGHT CORONARY ARTERY (RCA) LESION. AN IVUS CATHETER WAS ADVANCED INTO THE DISTAL (RCA) LESION AND IMAGES WERE OBTAINED, THE CATHETER WAS THEN REMOVED. A 2.5X12MM NON-MDT NON-COMPLIANT BALLOON WAS INFLATED AT 15 ATM FOR 10 SECONDS ACROSS THE DISTAL RIGHT CORONARY ARTERY (RCA). THIS WAS REPEATED THREE TIMES. THE BALLOON WAS RE-INFLATED AT 20 ATM FOR 10 SECONDS AND 26 ATM FOR 10 SECONDS ACROSS THE MID RIGHT CORONARY (RCA) LESION. THE BALLOON WAS REMOVED. THE 2.75X34MM RESOLUTE ONYX RX DEVI

  Patient problems: Insufficient Information

  MAUDE report 14560006 ↗
• DeathNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE LAD. APPROXIMATELY 27 MONTHS POST PROCEDURE PATIENT SUFFERED FROM RESPIRATORY FAILURE AND WAS TREATED WITH MEDICATION. THE PATIENT DIED. DEATH WAS CLASSIFIED AS NON-SUDDEN CARDIAC DEATH.

  Patient problems: Respiratory Failure

  MAUDE report 12743339 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MILDLY CALCIFIED LESION LOCATED IN THE MID TO DISTAL CX ARTERY. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE DEVICE WAS ADVANCED OVER THE WIRE FOR PRIMARY STENTING AND INFLATED AT 14 ATM'S. AN ANGIOGRAM WAS PERFORMED AND A PERFORATION AT THE DISTAL END OF THE STENT AND VESSEL WAS OBSERVED. A EUPHORA BALLOON WAS ADVANCED INTO THE PROXIMAL PORTION OF THE STENT AND INFLATED AT 14ATM. THE BALLOON WAS REMOVED. PROTAMINE WAS GIVEN, HOWEVER EXTRAVASATION WAS STILL NOTED. A NON-MEDTRONIC BALLOON WAS INSERTED INTO RESOLUTE ONYX STENT AND INFLATED FOR TEN MINUTES. EXTRAVASATION WAS STILL NOTED. A NON-MEDTRONIC STENT WAS INSERTED INTO THE DISTAL END

  Patient problems: Perforation; Thrombus

  MAUDE report 7796465 ↗
• MalfunctionMay 29, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION, LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 80% STENOSIS. 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 DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO ADVANCE THE DEVICE BUT IT WAS NOT POSSIBLE TO GET TO THE DESIRED LOCATION. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE END OF THE STENT WAS FRAYED. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY. THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTE ONYX DEVICE (RONYX27522UX).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7548085 ↗
• MalfunctionMar 28, 2018Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION IN THE MID RCA. IT IS REPORTED THAT THE STENT WAS UNABLE TO CROSS THE LESION AND THE STENT STRUT WAS BENT WHEN REMOVED. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7377361 ↗
• MalfunctionDec 18, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE TWO RESOLUTE ONYX RX DRUG ELUTING STENTS (THE FIRST DEVICE IS RONYX27534UX AND THE SECOND DEVICE RONYX27538UX) TO TREAT A LESION. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO DEVICES PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. NEGATIVE PREP WAS PERFORMED ON THE DEVICES WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN-VIVO DURING POSITIONING. IN EACH CASE THE DEVICES WERE REPLACED BY A RESOLUTE ONYX OF THE SAME SIZE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125893 ↗