Resolute Onyx™ RONYX40026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169557192), received between Jan 22, 2018 and Jun 10, 2022 — classified as 1 death, 6 injuries, 8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED. IT WAS REPORTED THAT THE WIRE FROM THE STENT BROKE OFF IN THE AORTA AND REMAINS THERE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652485 ↗
• MalfunctionOct 5, 2021Use of Device Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT AN EXPIRED STENT WAS USED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12575273 ↗
• MalfunctionSep 22, 2021Use of Device Problem; Use of Device Problem

  A RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION IN THE PROXIMAL SAPHENOUS VEIN GRAFT (SVG). THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT AN EXPIRED DEVICE WAS USED. THE EXPIRATION DATE WAS NOT CONFIRMED UNTIL AFTER THE STENT WAS IMPLANTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12512722 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX WAS IMPLANTED IN THE LAD, ONE RESOLUTE ONYX WAS IMPLANTED IN THE R-PDA, ONE RESOLUTE ONYX WAS IMPLANTED IN THE RCA AND ONE RESOLUTE ONYX WAS IMPLANTED IN THE 1ST RPL. APPROXIMATELY 19 MONTHS POST PROCEDURE PATIENT SUFFERED STENT THROMBOSIS RELATED TO THE RESOLUTE ONYX IMPLANTED IN THE RCA. EVENT WAS TREATED WITH HIGH PRESSURE BALLOON DILATION. PATIENT RECOVERED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11469662 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX WAS IMPLANTED IN THE LAD, ONE RESOLUTE ONYX WAS IMPLANTED IN THE R-PDA, ONE RESOLUTE ONYX WAS IMPLANTED IN THE RCA AND ONE RESOLUTE ONYX WAS IMPLANTED IN THE 1ST RPL. SIX NC EUPHORA BALLOONS WERE ALSO USED DURING THE INDEX PROCEDURE. APPROXIMATELY 19 MONTHS POST PROCEDURE PATIENT SUFFERED MYOCARDIAL INFARCTION INVOLVING THE RCA (TARGET VESSEL). ANGIOGRAM REVEALED IN-STENT RESTENOSIS. THE EVENT WAS TREATED WITH TARGET LESION REVASCULARIZATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 11451278 ↗
• MalfunctionMar 8, 2021Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT WAS NOTED TO BE UNDER EXPANDED AND BALLOON DILATION HAD TO BE PERFORMED. THE PATIENT WAS REPORTED TO HAVE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11434405 ↗
• DeathNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED - ONE WAS IMPLANTED IN THE LAD AND ONE WAS IMPLANTED IN THE RCA. APPROXIMATELY 30 MONTHS POST PROCEDURE, PATIENT SUFFERED PRE-EXISTING END STAGE RENAL DISEASE AND DIED THE SAME DAY WHILE IN HOSPICE CARE. THE DEATH WAS CLASSIFIED AS A NON CARDIAC DEATH. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. CEC ADJUDICATED THE EVENT AS CARDIAC DEATH.

  Patient problems: Renal Failure

  MAUDE report 10868108 ↗
• MalfunctionSep 4, 2020Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A MILDLY STENOTIC LESION IN THE RCA. IT WAS REPORTED THAT THE STENT COULD NOT CROSS THE LESION AND THE STENT DEFORMED. ANOTHER RESOLUTE ONYX STENT (3.5 X 26MM) WAS USED TO COMPLETE THE PROCEDURE AFTER LESION WAS DILATED WITH BALLOON. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10493087 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE FOUR RESOLUTE ONYX RX DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A BILATERAL PULMONARY EMBOLI. THE PATIENT WAS TREATED WITH MEDICATION AND HOSPITALIZATION. THE PATIENT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICES OR ANTIPLATELET MEDICATION.

  Patient problems: Embolism; Embolism/Embolus; Myocardial Infarction

  MAUDE report 10447212 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT (DES) AND ONE NC EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE RESOLUTE ONYX DES WAS IMPLANTED. THERE WAS NO ISSUES NOTED OR OBSERVED DURING DEPLOYMENT OF THE STENT. IT WAS STATED THAT POST DILATION OF THE NC EUPHORA BALLOON AT 18 ATM WITHIN THE RESOLUTE ONYX STENT RESULTED IN A PERFORATION. IT IS UNCLEAR WHETHER THE STENT OR THE BALLOON CAUSED THE PERFORATION. IT WAS INDICATED THAT THE BALLOON AND STENT WERE NOT BELIEVED TO BE THE PRIMARY CAUSE OF THE PERFORATION EVENT. IT WAS INDICATED THAT THE EVENT MAY HAVE BEEN ASSOCIATED WITH THE SIGNIFICANT CALCIUM DEPOSITS WITHIN THE ARTERY. THE PERFORATION WAS TREATED WITH A COVERED CORONARY STENT. THE PATIENT WAS REPORTED TO BE ALI

  Patient problems: Injury; Perforation

  MAUDE report 9804490 ↗
• MalfunctionFeb 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX (4.00 X 26MM) AND ONE RESOLUTE ONYX RX (2.25 X 18MM) DRUG ELUTING STENTS TO TREAT A LESION. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE LESIONS WERE NOT PRE-DILATED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX RX (4.00 X 26MM) DEVICE. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX RX (2.25 X 18MM) DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF EITHER DEVICE. IT WAS REPORTED THAT BOTH STENTS DISLODGED DURING REMOVAL FOLLOWING FAILED DELIVERIES. IT WAS REPORTED THAT AFTER THE RESOLUTE ONYX RX (4.00 X 26MM) FAILED TO CROSS THE LESION IT WAS PULLED BACK INTO THE Y ADAPTER. THE STENT THEN GOT "HUNG UP" ON THE Y ADAPTER AND CAME OFF THE DELIVERY CATHETER. IT WAS REPORTED THAT THE RESOLUTE ONYX RX (2.25 X 18MM) DISLODGED IN THE Y ADAPTER. BOTH DEVICES WERE RETRIEVED SUCCESSFULLY. THE DISLODGED STENTS WERE REMOVED BY THE PHYSICIANS HAND. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9710349 ↗
• MalfunctionJan 29, 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 MODERATELY TORTUOUS AND CALCIFIED LESION IN THE MID LAD. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PREDILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT WAS FOUND IN THE GUIDE AND WAS REMOVED FROM THE PATIENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641724 ↗
• InjuryJun 28, 2019Adverse 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 RCA. CEC ADJUDICATED A NON-Q-WAVE MI OF THE TARGET VESSEL RCA, 3RD UDMI PERI-PCI OCCURRED THE SAME DAY.

  Patient problems: Myocardial Infarction

  MAUDE report 8743151 ↗
• MalfunctionMar 7, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION. THERE WERE NO ABNORMALITIES REPORTED 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 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 STENT DEFORMATION OCCURRED IN-VIVO DURING POSITIONING. IT WAS DESCRIBED THAT THE PHYSICIAN TRIED A NUMBER OF TIMES TO PLACE THE STENT IN A HIGHLY CALCIFIED AREA AND DURING THIS TIME ONE OF THE STENT STRUTS LIFTED. IT WAS ALSO REPORTED THAT THE PHYSICIAN THEN PRE DILATED THE LESION AGAIN AND COMPLETED THE PROCEDURE USING A NON-MEDTRONIC STENT. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7320563 ↗
• InjuryJan 22, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED USING A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION IN THE MID RCA. THE LESION HAD HEAVY CALCIUM, 90% STENOSIS, AND MODERATE TORTUOSITY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE STENT WAS INSPECTED POST REMOVAL OF THE PROTECTIVE SHEATH WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT OR CELL OF A STENT. IT IS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY CROSSING THE LESION, AND ATTEMPTED TO PULL THE DEVICE BACK. IT THEN DISLODGED FROM THE DELIVERY SYSTEM. EXCESSIVE FORCE WAS NOT USED. THE PHYSICIAN BALLOONED AND CRUSHED THE STENT IN POSITION, THEN PLACED A NON-MDT STENT.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7208903 ↗