Resolute Onyx™ RONYX25034UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00643169556850), received between Nov 6, 2017 and Jun 15, 2023 — classified as 3 deaths, 11 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT (DES) WAS IMPLANTED. IT WAS REPORT THAT THE PATIENT HAD AN ANEURYSM POST PLACEMENT SIX MONTHS AGO. THE PATIENT EXPRESSED CONCERNS ABOUT GETTING A MRI (MAGNETIC RESONANCE IMAGING) IN A VERTICAL MAGNET. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Aneurysm

  MAUDE report 17133549 ↗
• MalfunctionJan 18, 2022Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13280711 ↗
• MalfunctionAug 18, 2021Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 95% STENOSIS, IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED A STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING TWO OTHER RESOLUTE ONYX DRUG ELUTING STENTS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12335520 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT HAD A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT (RONYX22526UX) IMPLANTED ON THE (B)(6) 2021. ONE WEEK POST PROCEDURE THE PATIENT EXPERIENCED A RASH. IT WAS LATER REPORTED THAT A RESOLUTE ONYX CORONARY DRUG ELUTING STENT (RONYX25034UX) WAS INITIALLY IMPLANTED ON THE (B)(6) 2020. THREE DAYS AFTER THIS STENT WAS IMPLANTED THE PATIENT DEVELOPED A RASH, AND THEN 10 DAYS LATER BLISTERS DEVELOPED ON THE PATIENT'S ANKLES. AN ALLERGY TEST WAS DONE SHOWING HYPERSENSITIVITY TO NICKEL WHICH WAS NOT KNOWN PRE-OP. ON THE (B)(6) 2021, THE PATIENT ATTENDED THE EMERGENCY ROOM DUE TO THE LEG RASH, AND WAS DIAGNOSED WITH CELLULITIS AND PUT ON ANTIBIOTICS. THE PATIENT'S PRIMARY CARE PROVIDER HAS SINCE DIAGNOSED THE PATIENT WITH DERMATITIS FOR WHICH THE PATIENT IS CURRENTLY TAKING PREDNISOLONE. THE PHYSICIAN BELIEVES THAT THE EVENT IS NOT RELATED TO THE DEVICE.

  Patient problems: Local Reaction; Unspecified Tissue Injury

  MAUDE report 12098166 ↗
• MalfunctionJun 9, 2021Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE TELESCOPE GUIDE EXTENSION CATHETER WERE ATTEMPTED TO BE USED TO TREAT A MODERATELY CALCIFIED LESION. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE RESOLUTE ONYX DEVICE WAS NEGATIVELY PREPPED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A BALLOON AND THEN A SHOCKWAVE IVL WAS USED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE RESOLUTE ONYX DEVICE. IT WAS REPORTED THAT THE STENT FAILED TO PASS SO IT WAS PULLED BACK THROUGH THE TELESCOPE AND GUIDE CATHETER AND STENT DEFORMATION OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11966082 ↗
• MalfunctionFeb 3, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED LESION LOCATED IN THE MID/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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/ADVANCEMENT. IT WAS STATED THAT THE STENT BUCKLED IN THE MIDDLE AND WAS STILL ATTACHED TO THE BALLOON. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11271377 ↗
• InjuryNov 24, 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 TO TREAT A LESION. CEC ADJUDICATED THAT ON THE NEXT DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM TARGET VESSEL MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 10894830 ↗
• InjuryNov 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD. ONE RESOLUTE ONYX DES WAS IMPLANTED DURING ANOTHER REVASC TO TREAT THE 1ST OBTUSE MARGINAL. APPROXIMATELY 34 MONTHS LATER, THE PATIENT SUFFERED MI. EVENT WAS TREATED WITH HOSPITALIZATION, MEDICATION AND PCI. PATIENT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR THE ANTI-PLATELET MEDICATION. SAFETY COMMENTED "REVASC NTV". STENTING WAS CARRIED OUT IN THE 1ST OBTUSE MARGINAL AND RCA DURING A REVASCULARIZATION PROCEDURE. CEC ADJUDICATED MI AS NON-Q-WAVE MI OF THE RCA AND THE CX (NON-TARGET VESSEL). CEC ADJUDICATED REVASCULARIZATION OF THE RCA AND CX AS NON-TVR-PCI.

  Patient problems: Myocardial Infarction

  MAUDE report 10866618 ↗
• InjuryJan 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, SIX RESOLUTE ONYX DRUG ELUTING STENT WERE IMPLANTED IN THE 2ND OBTUSE MARGINAL. FOLLOWING DAY, PATIENT SUFFERED ELEVATED CARDIAC ENZYMES. PATIENT RECOVERED. CEC ADJUDICATED EVENT A MYOCARDIAL INFARCTION WITH REVASCULARISATION CARRIED OUT IN THE CX AND 2ND OM FOLLOWING STENT THROMBOSIS EVENT TYPE. INVESTIGATOR ASSESSED EVENT IS CAUSALLY RELATED TO DEVICE AND NOT RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Myocardial Infarction; Thrombus

  MAUDE report 9640965 ↗
• MalfunctionNov 20, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND THE STENT STRUTS BECAME FLARED. THE PROCEDURE WAS COMPLETED USING A 2.5X18MM RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346872 ↗
• DeathSep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED IN THE LAD. APPROXIMATELY 18 MONTHS POST PROCEDURE, PATIENT DIED. CAUSE OF DEATH IS UNKNOWN.

  Patient problems: Death

  MAUDE report 9133519 ↗
• MalfunctionSep 11, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOSITY, LESION EXHIBITING 80% STENOSIS IN THE MID DISTAL RIGHT CORONARY ARTERY (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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING A BALLOON AS IT WASN'T POSSIBLE TO DELIVER A STENT. IT WAS REPORTED THAT THE PATIENT WAS PAIN FREE AND SYMPTOM FREE, SO HE IS GOING TO BE BROUGHT BACK IN A FEW WEEKS FOR CORONARY ATHERECTOMY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8991761 ↗
• InjuryMay 2, 2019Adverse 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 INTO THE CX AND TWO RESOLUTE ONYX STENTS WERE IMPLANTED IN THE LAD. ON THE SAME DAY, THE PATIENT SUFFERED PCI RELATED MI. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE BUT NOT RELATED TO THE ANTIPLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 8572323 ↗
• DeathApr 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX STENTS WERE IMPLANTED - ONE INTO THE CX AND ONE INTO THE LAD. ONE DAY POST INDEX PROCEDURE THE PATIENT SUFFERED ACUTE TROPONIN RELEASE. THE PATIENT IS RECOVERING. THE INVESTIGATOR ASSESSED THE EVENT AS UNLIKELY TO BE RELATED TO THE INDEX DEVICE BUT NOT RELATED TO ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT POSSIBLY RELATED TO THE INDEX DEVICE BUT NOT RELATED TO ANTI-PLATELET MEDICATION. CEC ASSESSED THE EVENT AS A NON Q WAVE MI OF THE TARGET VESSEL, 3RD UDMI PERI PCI.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 8472707 ↗
• InjuryMar 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING FROM THE HOOP. THE DEVICE WAS INSPECTED PRIOR TO USE. THE DEVICE PASSED THOUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF THE DEVICE. IT WAS REPORTED THAT THE STENT DISLODGED WHILE ATTEMPTING TO ADVANCE DOWN THE ARTERY. THE DISLODGED STENT WAS REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED USING A 2.5X18MM AND 2.5X23MM NON-MEDTRONIC STENT. THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION WITH NO FURTHER INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 8460433 ↗
• DeathFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO RESOLUTE ONYX STENTS WERE IMPLANTED - ONE INTO THE CX AND ONE INTO THE LAD. IT WAS REPORTED THAT FIVE DAYS POST INDEX PROCEDURE, THE PATIENT SUFFERED PULMONARY EMBOLISM. THE PI REPORTED A KNOWN RV THROMBUS. IT WAS REPORTED THAT THE PATIENT WENT INTO PEA ARREST. THE PATIENT WAS TREATED WITH MEDICATION AND COMPRESSION'S BUT PASSED AWAY. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Death; Embolism; Thrombus

  MAUDE report 8353655 ↗
• InjuryFeb 1, 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 LAD. PRE-PROCEDURE, PATIENTS TROPONIN WAS WITHIN NORMAL LIMITS, POST-PROCEDURE THE PATIENTS TROPONIN PEAKED AT 0.164 NG/ML, 3.64URL. CEC ADJUDICATED NON-Q-WAVE MI (TARGET VESSEL-LAD), MDT EXTENDED HISTORICAL PERI-PCI AND ADJUDICATED STENT THROMBOSIS NO EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 8295830 ↗
• InjuryJan 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 6 RESOLUTE ONYX DES WERE IMPLANTED IN THE CX. IT WAS REPORTED THAT THE LEFT CIRCUMFLEX ARTERY BECAME COMPLETELY OCCLUDED DURING THE INDEX PROCEDURE AND WAS TREATED WITH PLACEMENT OF A STENT. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTIPLATELET MEDICATION. PATIENT RECOVERED. SAFETY REPORTED PLAQUE SHIFT OCCURRED DURING PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 8280810 ↗
• InjuryNov 16, 2018Adverse 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 INSERTED INTO THE GUIDE CATHETER BUT NOT IMPLANTED. ON THE SAME DAY, THE PATIENT SUFFERED ELEVATED CARDIAC ENZYMES. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE CEC ADJUDICATED THE EVENT AS A NON Q WAVE MI (TARGET VESSEL) MDT EXTENDED HISTORICAL PERI-PCI. THE MI OCCURRED IN THE LAD. THE CEC ALSO ADJUDICATED STENT THROMBOSIS AS NO EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 8077666 ↗
• MalfunctionNov 20, 2017Material Deformation; Material Deformation

  IT IS REPORTED THAT A RESOLUTE ONYX DRUG ELUTING STENT BECAME DEFORMED DURING REMOVAL AFTER IT FAILED TO CROSS A LESION (IN STENT RESTENOSIS) IN THE PROXIMAL OM1. THE DAMAGE REPORTED WAS A STENT STRUT LIFTED. THE PROCEDURE WAS COMPLETED USING TWO 2.5X15MM ONYX DEVICES. NO PAEDIATRIC PATIENT WAS INVOLVED AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7044579 ↗
• InjuryNov 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THE 1ST LPL WAS TREATED WITH A RESOLUTE ONYX DES. THE DISTAL CX WAS TREATED WITH RESOLUTE ONYX DES. THE LESION WAS FURTHER TREATED BY ANOTHER RESOLUTE ONYX DES. APPROXIMATELY 3 WEEKS POST INDEX PROCEDURE THE PATIENT SUFFERED A NSTEMI. THE PATIENT WAS HOSPITALIZED. THE INVESTIGATOR REPORTED THAT THE EVENT HAD A PROBABLE RELATIONSHIP TO THE INDEX DEVICE. STENT THROMBOSIS WAS CONFIRMED BY ANGIO BUT THE DEVICE WAS A NON MDT STENT.

  Patient problems: Myocardial Infarction; Patient Problem/Medical Problem

  MAUDE report 7003131 ↗