Resolute Onyx™ RONYX40008UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169557147), received between Sep 29, 2017 and Feb 8, 2022 — classified as 2 deaths, 10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A NON-TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE OSTIUM OF THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH A EUPHORA BALLOON, AN NC EUPHORA BALLOON AND A CUTTING 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 THREE ATTEMPTS WERE MADE TO PASS THE OSTIAL LM, WHILE REALLY PUSHING THE STENT ACROSS INTO THE LAD, ALL FAILED AND WHEN PULLING THE STENT BACK INTO THE LM IT WAS NOTED TO HAVE MOVED POSITION ON THE BALLOON. THE DEVICE WAS THEN REMOVED THROUGH THE GUIDE WITH NO ISSUES NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13478550 ↗
• InjuryApr 19, 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 RCA. APPROXIMATELY 23 MONTHS POST PROCEDURE PATIENT SUFFERED OF PNEUMONIA SECONDARY TO COVID-19. MEDICATION WAS GIVEN AND THE PATIENT WAS TRANSFERRED TO COMFORT CARE, BUT PATIENT SUFFERED ACUTE RESPIRATORY FAILURE AND DIED A WEEK LATER. THE CAUSE OF DEATH WAS CLASSIFIED AS NON-CARDIAC. THE EVENT WAS TREATED WITH MEDICATION.

  Patient problems: Pneumonia

  MAUDE report 11684756 ↗
• DeathApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, THREE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN GRAFT 2ND OM AND GRAFT 3RD OM. APPROXIMATELY 16, PATIENT SUFFERED SUSTAINED VENTRICULAR TARCHYCARDIA AND DIED SAME DAY. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10013066 ↗
• MalfunctionAug 14, 2019Entrapment of Device; Device Dislodged or Dislocated; Entrapment of Device; Device Dislodged or Dislocated

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION. IT WAS REPORTED THAT THE STENT BECAME LODGED IN THE GUIDE CATHETER AND WAS UNABLE TO BE ADVANCED OR REMOVED. THE GUIDE WAS REMOVED WITH THE STENT REMAINING IN THE GUIDE AND A NEW GUIDE CATHETER WAS USED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8892109 ↗
• InjuryJun 28, 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 INTO THE RCA. APPROX 22 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED SUBARACHNOID HEMORRHAGE. THE PATIENT WAS TREATED WITH A CHANGE IN MEDICATION. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE BUT POSSIBLY RELATED TO ANTI-PLATELET MEDICATION.

  Patient problems: Stroke/CVA

  MAUDE report 8744116 ↗
• InjuryApr 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLAQUE SHIFT OCCURRED DURING IMPLANTATION OF TWO RESOLUTE ONYX STENTS (0008835623 AND 0008841599) IN THE 1ST DIAG INTO THE LAD DURING THE INDEX PROCEDURE. THE PLAQUE SHIFT WAS TREATED WITH THE IMPLANTATION OF ONE OTHER RESOLUTE ONYX STENT. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS CAUSALLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO ANTI-PLATELET MEDICATION. SPONSOR ASSESSED THE EVENT AS CAUSALLY RELATED TO THE DEVICE AND NOT RELATED TO THE ANTI-PLATELET MEDICATION.

  Patient problems: Occlusion

  MAUDE report 8477418 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE 1ST OBTUSE MARGINAL. THE MI OCCURRED IN THE 1ST OBTUSE MARGINAL. IT WAS REPORTED THAT THE PATIENTS TROPONIN LEVELS WERE ELEVATED POST PROCEDURE. CEC ADJUDICATED MI AS A NON Q WAVE MI (TARGET VESSEL) MDT EXTENDED HISTORICAL PERI-PCI. CEC ALSO ASSESSED STENT THROMBOSIS AS NO EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 8424235 ↗
• InjuryMar 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, THREE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE LAD. IT WAS REPORTED THAT THE PATIENTS TROPONIN LEVELS WERE ELEVATED POST PROCEDURE. CEC ADJUDICATED MI AS A NON Q WAVE MI (TARGET VESSEL) MDT EXTENDED HISTORICAL REINFARCTION POST PCI. CEC ALSO ASSESSED STENT THROMBOSIS AS NO EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 8417115 ↗
• 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 CX. CEC ADJUCIATED NON-Q-WAVE MI (TARGET VESSEL), MDT EXTENDED HISTORICAL PERI-PCI, SAME DAY AS THE INDEX PROCEDURE, AND ADJUDICATED STENT THROMBOSIS AS NO EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 8295885 ↗
• DeathDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE LEFT MAIN (LM) CORONARY ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE-DILATED USING A 2.5MM BALLOON. 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 WHILE ATTEMPTING TO STENT THE LEFT MAIN INTO THE LAD THAT THE STENT WAS DEPLOYED AT 18ATMS. AFTER DEPLOYING THE STENT THE BALLOON WAS REMOVED AND A PERFORATION WAS OBSERVED. AN ATTEMPT WAS MADE TO TREAT THE PERFORATION USING A STENT GRAFT AND OTHER BALLOONS; HOWEVER, WERE UNSUCCESSFUL. AN ATTEMPT WAS NEXT MADE TO TREAT THE PERFORATION USING A 4.00X08MM RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE 4.00X08MM RESOLUTE ONYX STENT WAS USED IN THE OSTIAL LEFT MAIN BUT FAILED TO TREAT THE PERFORATION. THE PATIENT IS REPORTED TO HAVE DIED ON THE SAME DAY AS THE PROCEDURE. IT IS INDICATED THAT THE CAUSE OF DATE WA

  Patient problems: Death

  MAUDE report 8159833 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE FIVE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; FOUR IN THE LAD AND ONE IN THE 1ST DIAGONAL AND TWO NC EUPHORA BALLOONS WERE USED IN THE LAD. ON THE SAME DAY THE PATIENT SUFFERED ELEVATED TROPONIN AND RECOVERED THE FOLLOWING DAY. CEC ADJUDICATED THE EVENT AS NON-Q WAVE MYOCARDIAL INFARCTION OF THE TARGET VESSEL. INVESTIGATOR ASSESSED THE EVENT IS UNLIKELY RELATED TO DEVICE AND NOT RELATED TO ANTIPLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 8150519 ↗
• InjuryOct 18, 2018Device Damaged by Another Device; Device Dislodged or Dislocated; Migration; Device Damaged by Another Device; Device Dislodged or Dislocated; Migration

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE 4.0X8MM RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON-TORTUOUS AND NON-CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT MAIN ARTERY. THE 4.0X8MM RESOLUTE ONYX WAS DEPLOYED IN MID LEFT MAIN TO COVER A DISSECTION. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 STENT EMBOLIZATION FROM LEFT MAIN ARTERY OCCURRED DUE TO INTERACTION WITH A NON MEDTRONIC GUIDE EXTENSION CATHETER. THE STENT WAS ADVANCED THROUGH A 3.5 EBU MEDTRONIC GUIDE CATHETER ALONG WITH A 6F NON-MEDTRONIC GUIDE EXTENSION CATHETER. UPON REMOVAL OF GUIDE EXTENSION CATHETER, THE STENT DISLODGED AND MOST OF STENT LENGTH WAS HANGING IN LEFT CORONARY CUSP WHILE THE DISTAL EDGE OF THE STENT WAS STILL BARELY INSIDE OSTIA LEFT MAIN. A NON-MEDTRONIC 5.0X15MM BALLOON HAD BEEN ADVANCED TO EXPAND AND CAPTURE THE STENT AND UPON REMOVAL OF CATHETER AND GUIDE

  Patient problems: Patient Problem/Medical Problem; Vascular Dissection

  MAUDE report 7978287 ↗
• InjuryJul 13, 2018Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DES AND ONE NC EUPHORA BALLOON WERE USED TO TREAT A LESION IN THE LCMA. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED RECTAL BLEEDING. LOWER GI BLEED LIKELY RELATED TO SEVERE INTERNAL HAEMORRHOIDS. PATIENT WAS ON DAPT AT THE TIME OF THE EVENT. THE EVENT WAS TREATED WITH MEDICATION & COLONOSCOPY. PATIENT IS RECOVERED. INVESTIGATOR INDICATED THAT EVENT WAS NOT RELATED TO THE DEVICE BUT PROBABLY RELATED TO THE ANTIPLATELET MEDICATION.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7684677 ↗
• MalfunctionMay 28, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE, ATTEMPTS WERE MADE TO USE TWO RESOLUTE ONYX DRUG ELUTING STENTS TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION, LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED. THE DEVICES DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. IT WAS REPORTED THAT ONE MEDTRONIC STENT (3.5X38 RESOLUTE ONYX) WAS SUCCESSFUL IMPLANTED IN THE RCA. AN ATTEMPT WAS THEN MADE TO PUSH A 4.0 X 08 RESOLUTE ONYX DES DISTAL TO THE FIRST STENT. HOWEVER, THE DEVICE COULD NOT PASS THROUGH THE DEPLOYED STENT. THE 4.0 X 08 DEVICE WAS THEN REMOVED AND LIFTED STRUTS WERE NOTED IN THE MIDDLE OF THE STENT. A GUIDELINER WAS USED AND ANOTHER ATTEMPT WAS MADE TO USE ANOTHER RESOLUTE ONYX 4.0X8. HOWEVER THE SAME PROBLEM OCCURRED. THE DEVICE COULD NOT CROSS THE DEPLOYED STENT AND THE STENT WAS THEN NOTED TO BE DEFORMED. THE PROCEDURE WAS COMPLETED USING A BALLOON. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7547750 ↗
• MalfunctionMay 28, 2018Material Deformation; Material Deformation

  DURING THE PROCEDURE, ATTEMPTS WERE MADE TO USE TWO RESOLUTE ONYX DRUG ELUTING STENTS TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION, LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED. THE DEVICES DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. IT WAS REPORTED THAT ONE MEDTRONIC STENT (3.5X38 RESOLUTE ONYX) WAS SUCCESSFUL IMPLANTED IN THE RCA. AN ATTEMPT WAS THEN MADE TO PUSH A 4.0 X 08 RESOLUTE ONYX DES DISTAL TO THE FIRST STENT. HOWEVER, THE DEVICE COULD NOT PASS THROUGH THE DEPLOYED STENT. THE 4.0 X 08 DEVICE WAS THEN REMOVED AND LIFTED STRUTS WERE NOTED IN THE MIDDLE OF THE STENT. A GUIDELINER WAS USED AND ANOTHER ATTEMPT WAS MADE TO USE ANOTHER RESOLUTE ONYX 4.0X8. HOWEVER THE SAME PROBLEM OCCURRED. THE DEVICE COULD NOT CROSS THE DEPLOYED STENT AND THE STENT WAS THEN NOTED TO BE DEFORMED. THE PROCEDURE WAS COMPLETED USING A BALLOON. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7547746 ↗
• InjurySep 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDEX PROCEDURE WAS PROMPTED BY A MYOCARDIAL INFARCTION. DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE PROXIMAL LAD TO TREAT THE MYOCARDIAL INFARCTION. THE PATIENT SUFFERED A DISSECTION IN THE PROXIMAL LAD DURING THE PROCEDURE. THIS WAS TREATED BY IMPLANTING A THIRD RESOLUTE ONYX DRUG ELUTING STENT. THE PATIENT RECOVERED.

  Patient problems: Intimal Dissection

  MAUDE report 6903275 ↗