Resolute Onyx™ RONYX40012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169557154), received between Dec 20, 2017 and Jun 14, 2022 — classified as 6 deaths, 5 injuries, 4 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.

• DeathJun 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. IT WAS DETAILED THAT THE DISLODGED STENT WAS LATER FOUND IN THE LEFT VENTRICLE NEAR THE MITRAL VALVE HOWEVER, THE DEVICE WAS NOT REMOVED. A NON-MEDTRONIC STENT WAS USED TO TREAT THE RIGHT CORONARY ARTERY. IT WAS DETAILED THAT THE PATIENT SUFFERED A STROKE. IT WAS REPORTED THAT THE PATIENT DIED.

  Patient problems: Insufficient Information; Stroke/CVA

  MAUDE report 14684832 ↗
• InjuryApr 19, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE OBTUSE MARGINAL (OM) ARTERY. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE DEVICE WAS ATTEMPTED TO CROSS AT THE OSTIAL OF THE SAPHENOUS VEINS GRAFT. THE DEVICE DISLODGEMENT OCCURRED DURING DELIVERY AT THE LESION. THE DEVICE WAS JAMMED AND CAME OFF THE BALLOON. IT WAS REPORTED THAT NEGATIVE PRESSURE WAS NOT DRAWN ON THE DELIVERY SYSTEM. THE DISLODGED STENT WAS REMOVED USING A SNARE. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14141942 ↗
• MalfunctionJun 15, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND MILDLY TORTUOUS LESION EXHIBITING 95% STENOSIS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OR ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. 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. IT WAS REPORTED THAT THE DELIVERY SHAFT OF STENT BROKE ON ADVANCING IN GUIDE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11997643 ↗
• MalfunctionDec 11, 2020Inflation Problem; Inflation Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 70% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID 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 INFLATION DIFFICULTIES OCCURRED DURING STENT DEPLOYMENT. IT WAS STATED THAT THE INFLATION PRESSURE WENT FROM NOMINAL OF 12ATM TO 18ATM, HOWEVER THE INFLATION DID NOT SUSTAIN AND PRESSURE GRADUALLY DROPPED. THE STENT WAS IMPLANTED AND POST DILATION WAS PERFORMED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10990434 ↗
• DeathDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE RCA AND LAD. ONE WEEK LATER AS STAGED PROCEDURE WAS CARRIED OUT AND A RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED IN THE 1ST OM. APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE AND 17 MONTHS POST STAGED PROCEDURE, PATIENT SUFFERED MYOCARDIAL INFARCTION OF UNKNOWN TARGET VESSEL AND DIED. DEATH IS CLASSED AS SUDDEN CARDIAC DEATH. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO STUDY DEVICE AND NOT RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 10935372 ↗
• MalfunctionAug 24, 2020Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, AND CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID 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 STENT DEFORMATION OCCURRED WHILE CROSSING THROUGH A PREVIOUSLY DEPLOYED STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10442041 ↗
• DeathMay 15, 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 1ST OBTUSE MARGINAL. APPROXIMATELY 15 MONTHS LATER, THE PATIENT SUFFERED PAROXYSMAL SUPRAVENTRICLUAR TACHYCARDIA TREATED WITH CATHETER ABLATION BUT A SUDDEN CARDIAC DEATH OCCURRED. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE.

  Patient problems: Death

  MAUDE report 10060434 ↗
• DeathFeb 10, 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 GRAFT 1ST DIAGONAL. APPROXIMATELY 22 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM CARDIAC ARREST AND DIED ON THE SAME DAY. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. CEC ADJUDICATED THE DEATH END POINT AS VASCULAR DEATH.

  Patient problems: Death

  MAUDE report 9687421 ↗
• DeathAug 7, 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 1ST DIAGONAL. IT WAS REPORTED THE PATIENT DIED. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 8868606 ↗
• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX WAS IMPLANTED IN THE LAD AND TWO RESOLUTE ONYX STENTS WERE ALSO IMPLANTED IN THE CX. PLAQUE SHIFT OCCURRED IN THE LAD AND CX INTO THE LCMA WHICH WAS TREATED WITH THE IMPLANTATION OF TWO FURTHER RESOLUTE ONYX STENTS; ONE IN THE LAD AND ANOTHER IN THE CX WITH TWO NC EUPHORA BALLOONS TO POST DILATE. IT WAS ALSO REPORTED THAT THREE NC EUPHORA PTA BALLOONS WERE USED TO PRE DILATE THE VESSELS PRIOR TO TREATMENT. INVESTIGATOR ASSESSED THE EVENT AS CASUALLY RELATED TO THE INDEX DEVICE BUT NOT RELATED TO THE ANTIPLATELET MEDICATION.

  Patient problems: Occlusion

  MAUDE report 8738866 ↗
• InjuryApr 9, 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 RCA. APPROXIMATELY 4 DAYS POST INDEX PROCEDURE THE PATIENT SUFFERED A TRANSIENT ISCHEMIC ATTACK (TIA). THE PATIENT RECOVERED. THE INVESTIGATOR AND SPONSOR ASSESSED THAT THE EVENT IS NOT RELATED TO THE INDEX DEVICE OR ANTI PLATELETS. THE CEC ADJUDICATED THE EVENT AS AN EMBOLIC ISCHEMIC STROKE. THE CEC ADJUDICATED THE EVENT DATE AS (B)(6) 2019.

  Patient problems: Stroke/CVA

  MAUDE report 8495386 ↗
• MalfunctionDec 19, 2018Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION LOCATED IN THE OSTIUM OF LEFT MAIN CORONARY ARTERY AND THE CIRCUMFLEX (CX) ARTERY. AN ATTEMPT WAS FIRST MADE TO USE A 4.00X12MM RESOLUTE ONYX STENT. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED DURING STENT DEPLOYMENT ON THE FIRST INFLATION TO 10ATM. A NON COMPLIANT BALLOON WAS USED TO PROPERLY DEPLOY THE STENT. AN ATTEMPT WAS THEN MADE TO USE A 2.50X08MM RESOLUTE ONYX STENT. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS 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 A BALLOON RUPTURE OCCURRED DURING STENT DEPLOYMENT ON THE FIRST INFLATION TO 8ATM. A NON COMPLIANT BALLOON WAS U

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179090 ↗
• DeathMay 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDICATIONS INCLUDED NON-ST ELEVATION AND NON-ACUTE MI. THE PATIENT WAS IN A STATE OF HEART FAILURE WITHIN TWO WEEKS OF THE INITIAL PROCEDURE. FIVE RESOLUTE ONYX DRUG ELUTING STENT DEVICES WERE USED TO TREAT MILDLY TORTUOUS, MODERATELY CALCIFIED LESIONS IN THE PROXIMAL RCA AND MID CIRCUMFLEX ARTERY ((B)(6) 2018). THERE WAS 90% STENOSIS IN THE PROX RCA, 80% STENOSIS IN THE MID RCA, 90% IN THE MID CIRCUMFLEX AND 70% IN THE PROXIMAL CIRCUMFLEX, AND UP TO 99% STENOSIS IN THE DISTAL LAD. THE MID CX LESION SHOWED EVIDENCE OF THROMBUS PRESENCE AND RUPTURED PLAQUE. THE PROCEDURE WAS URGENT. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED. THERE IS NO ALLEGED PRODUCT ISSUE. ONE 3.5X30MM RESOLUTE ONYX STENT, AND ONE NC EUPHORA BALLOON WERE SUCCESSFULLY IMPLANTED IN THE MID CX AT 14 ATM. ONE 4.0X12MM RESOLUTE ONYX STENT WAS SUCCESSFULLY IMPLANTED IN THE PROX CX AT 16 ATM.

  Patient problems: Death; Patient Problem/Medical Problem; Thrombus

  MAUDE report 7553066 ↗
• InjuryApr 11, 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 IMPLANTED IN THE 1ST DIAGONAL TO TREAT A DE NOVO LESION. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED NON-STEMI. IT WAS REPORTED THAT THE PATIENT PRESENTED CHEST PAIN AND ELEVATED TROPONIN. THE EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. THE EVENT IS UNRESOLVED.

  Patient problems: Myocardial Infarction

  MAUDE report 7420753 ↗
• InjuryDec 20, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE TWO RESOLUTE ONYX DRUG ELUTING STENT DEVICES ((B)(4)) TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE OSTIUM OF A MAMMARY GRAFT. NO ISSUES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE (B)(4) WAS INSPECTED WITH NO ISSUES HOWEVER THE (B)(4) WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES FOR BOTH DEVICES. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING THE DELIVERY OF THE DEVICES. IT IS REPORTED THAT BOTH STENTS DISLODGED DURING DELIVERY TO /AT THE LESION. THE FIRST DEVICE ((B)(4)) WAS NOT REMOVED FROM THE PATIENT. THE STENT WAS DEPLOYED AT THE LESION, USING A 4.0 X 12 RESOLUTE ONYX BALLOON AND POST-DILATED. THE SECOND DEVICE ((B)(4)) WAS REMOVED FROM THE PATIENT USING A LOW PROFILE BALLOON, A EUPHORA RX 1.5 X 15. NO PATIENT INJURY IS REPORTED.

  Patient problems: Intimal Dissection; Patient Problem/Medical Problem

  MAUDE report 7132893 ↗