Resolute Onyx™ RONYX40022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169557185), received between Jul 31, 2017 and Sep 9, 2024 — classified as 2 deaths, 8 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2024Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE OSTIUM AND THE PROXIMAL OF THE LEFT MAIN (LM) CORONARY ARTERY AND THE CIRCUMFLEX (CX) ARTERY. 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 WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. IT WAS STATED THAT AN ATTEMPT WAS MADE TO DELIVER THE STENT TO THE LESION WITH A GUIDE EXTENSION CATHETER BUT THE STENT FAILED TO DELIVER AND WAS REMOVED. THE STENT DISLODGEMENT WAS NOT NOTED UNTIL AN ATTEMPT WAS MADE TO USE AND PUT THE STENT BACK INTO THE PATIENT. THE DISLODGED STENT WAS CRUSHED WITH ANOTHER STENT AGAINST THE VESSEL WALL. IT WAS STATED THE STENT LIKELY DISLODGED DUE TO INTERACTION WITH THE GUIDE EXTENSION CATHETER. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 20167523 ↗
• MalfunctionMay 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A TORTUOUS LESION IN THE PROXIMAL CIRCUMFLEX ARTERY (CX). IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND THE STENT CAME OFF THE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14540784 ↗
• MalfunctionMar 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE SAPHENOUS VEIN GRAFT (SVG). IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND STENT DISLODGEMENT OCCURRED AFTER THE DEVICE HAD BEEN REMOVED FROM THE PATIENT. IT WAS STATED THAT THE DEVICE WAS REMOVED FROM THE PATIENT AND WHEN RINSING THE DEVICE IN A BOWL OF STERILE WATER ON THE SURGICAL TABLE, THE STENT DISLODGED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711513 ↗
• MalfunctionNov 26, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT AND AN NC EUPHORA BALLOON CATHETER TO TREAT A LIMITED TORTUOUS LESION WITH 85% STENOSIS IN THE MID LAD. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. THE DEVICES WERE NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT A STENT DISLODGEMENT OCCURRED AT THE CATHETER DURING ADVANCEMENT THROUGH THE NON-MEDTRONIC (MDT) GUIDE CATHETER. IT WAS ALSO REPORTED THAT THE NC EUPHORA CATHETER BECAME DETACHED IN TWO PIECES IN THE GUIDE CATHETER. IT WAS SUGGESTED THAT THE BALLOON MAY HAVE BECOME TWISTED DUE TO TWO NON-MDT GUIDE WIRES INSIDE THE GUIDE CATHETER. IT WAS ATTEMPTED TO PASS THE RESOLUTE ONYX THOUGH AND WAS ALSO SUGGESTED THAT THE STENT BECAME PARTIALLY DISLODGED OR GOT CAUGHT WITH THE BALLOON. THE DEVICES WERE EASILY REMOVED. THE DEVICES NEVER REACHED THE PATIENT VESSEL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12877333 ↗
• DeathOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE MID LAD. APPROXIMATELY 27 MONTHS POST THE INDEX PROCEDURE THE SITE LEARNED THROUGH A CARE PROVIDED THAT THE PATIENT WAS DECEASED DUE TO CONGESTIVE HEART FAILURE (OBITUARY). THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DRUG OR THE DEVICE. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION OR THE DRUG. DEATH WAS CLASSIFIED AS NON-SUDDEN CARDIAC DEATH.

  Patient problems: Death

  MAUDE report 10716750 ↗
• MalfunctionSep 4, 2020Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  DURING A PROCEDURE, IT WAS INTENDED TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH 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 LUER LOCK OF THE DEVICE WAS NOTED TO BE MALFORMED. IT WAS STATED THAT INFLATION DIFFICULTIES OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10492810 ↗
• InjurySep 3, 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 THE PATIENT SUFFERED MYOCARDIAL INFARCTION IN THE LAD (TARGET VESSEL).

  Patient problems: Myocardial Infarction

  MAUDE report 10486952 ↗
• InjuryJan 17, 2020Adverse 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. DURING A REVASCULARIZATION, 2 RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA, ON THE SAME DAY OF THE FIRST REVASCULARIZATION, A SECOND REVASCULARIZATION WAS PERFORMED AND ANOTHER 2 RESOLUTE ONYX DES WERE IMPLANTED, ONE IN THE RCA AND ONE IN THE 2ND RPL. APPROXIMATELY 13 MONTHS POST PROCEDURE, AND 10 MONTHS POST REVASCULARIZATIONS, PATIENT SUFFERED NSTEMI IN THE RCA. EVENT WAS TREATED WITH 2 RESOLUTE ONYX DES STENTS IMPLANTED IN THE RCA. SHORTLY AFTER PROCEDURE PATIENT BECAME SHORT OF BREATH, EKG SHOWED STEMI AND WAS TREATED WITH ANOTHER PCI. PATIENT RECOVERED. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET MEDICATIONS.

  Patient problems: Myocardial Infarction

  MAUDE report 9602150 ↗
• InjuryJan 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REVASCULARIZATION, 2 RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA, ON THE SAME DAY OF THE FIRST REVASCULARIZATION, A SECOND REVASCULARIZATION WAS PERFORMED AND 2 RESOLUTE ONYX DES WERE IMPLANTED, ONE IN THE RCA AND ONE IN THE 2ND RPL. APPROXIMATELY 9 MONTHS POST FIRST AND SECOND REVASCULARIZATION, DURING A THIRD REVASCULARIZATION WAS PERFORMED AND TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. IT WAS REPORTED THAT DURING THE REVASCULARIZATION, PATIENT SUFFERED FROM THROMBUS IN THE RCA CAUSING AN ABRUPT CLOSURE OF THE RCA. EVENT WAS SUCCESSFULLY TREATED WITH A MEDTRONIC BMS. SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, BUT POSSIBLY RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Injury; Occlusion; Thrombus

  MAUDE report 9596138 ↗
• InjurySep 16, 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, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE CIRCUMFLEX AND TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. APPROXIMATELY 1 DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION OF THE TARGET VESSEL (LAD AND CX). INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9069647 ↗
• MalfunctionSep 11, 2019Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS INTENDED TO BE USED TO TREAT A MODERATELY CALCIFIED, SEVERELY TORTUOUS LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE DEVICE WAS NOT KINKED AND RE STRAIGHTENED. IT WAS REPORTED THAT WHILE LOADING THE STENT ON THE WIRE INTO A 5.5 GUIDE LINER THE RESLOLUTE ONYX DEVICE WOULDN¿T GO INTO THE GUIDE LINER AND ON REMOVAL OF THE ONYX DEVICE FROM THE BODY, IT WAS NOTICED THAT THE STENT HAD MOVED BACK OFF OF THE BALLOON. IT IS ALSO INDICATED THAT A DEVICE DETACHMENT OCCURRED DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8991191 ↗
• InjuryMar 4, 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. THE SAME DAY PATIENT SUFFERED ABRUPT ARTERY CLOSURE. IVUS REVEALED SOME DIFFUSE PLAQUE BUT NO EVIDENCE OF DISSECTION. PATIENT WAS TREATED WITH MEDICATION AND RECOVERED. INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO THE ANTI-PLATELET MEDIATION.

  Patient problems: Occlusion

  MAUDE report 8385726 ↗
• 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; Perforation

  MAUDE report 8159765 ↗
• InjuryApr 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND MILDLY TORTUOUS LESION, EXHIBITING 98% LESION STENOSIS BETWEEN THE MID TO PROXIMAL SAPHENOUS VEIN GRAFT. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUE IDENTIFIED. NEGATIVE PREP WAS ALSO PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. 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 STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DISLODGED STENT WAS REMOVED USING A SNARE. PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7395084 ↗
• MalfunctionJan 17, 2018Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE OSTIUM OF THE RCA VIA A SAPHENOUS VEIN GRAFT (SVG). THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A 2.5X20MM NON-MDT BALLOON. 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 IS REPORTED THAT THE STENT FAILED TO CROSS THE CALCIFIED LESION. WHEN THE STENT WAS REMOVED IT WAS NOTED THAT THE PROXIMAL END OF THE STENT HAD RAISED STRUTS. A 4.0X26MM RESOLUTE ONYX STENT WAS THEN PLACED WITH A NON MEDTRONIC GUIDE EXTENSION CATHETER TO ADD SUPPORT AND THE STENT WAS SUCCESSFULLY DEPLOYED. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7198786 ↗
• MalfunctionNov 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION IN THE TIBIOPERONEAL TRUNK. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. THERE WAS MODERATE TORTUOSITY IN THE ILIACS, HOWEVER THE SHEATH WAS ADVANCED INTO THE SFA AND A GUIDER PLACED THROUGHOUT THE SFA TO PREVENT THE STENT FROM DRAGGING IN NATIVE TISSUE. THE CATHETER SHAFT WOULD NOT ADVANCE TO THE LESION, SO IT NEVER CROSSED THE LESION. THE SHAFT BENT DURING ADVANCEMENT WHICH PREVENTED FURTHER ADVANCEMENT; WITH CONTINUOUS SMALL MOVEMENT ADVANCEMENTS THE SHAFT CONTINUED TO BEND PREVENTING FURTHER ADVANCEMENT. IT WAS REPORTED THAT THE RESOLUTE ONYX CATHETER SHAFT CRACKED DURING REMOVAL OF THE DEVICE FROM THE PATIENT. THE PORTION OF THE CATHETER SHAFT WHICH CRACKED WAS INSIDE THE PATIENT, DISTAL TO THE HAEMOSTATIC VALVE. THE DEVICE CRACKED AND WAS HANGING BY A THREAD AND REMOVED SLOWLY BY PULLING BACK THE DELIVERY SYSTEM. NO INTERVENTION WAS USED. THE DEVICE DID NOT BREAK IN TWO. THE RESOLUTE ONYX STENT WAS INTACT ON DELIVERY SY

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7066829 ↗
• InjuryJul 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDEX PROCEDURE WAS PROMPTED BY POSITIVE FUNCTIONAL STRESS TEST. A RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE LAD DURING THE INDEX PROCEDURE. ON THE SAME DAY OF INDEX PROCEDURE, PATIENT SUFFERED MI AND OCCLUSION IN THE TARGET VESSEL (NO REFLOW IN THE CORONARY ARTERY POST STENT DEPLOYMENT) AND WAS TREATED WITH MEDICATION. INVESTIGATOR ASSESSED THAT THE EVENT IS PROBABLY RELATED TO THE STUDY DEVICE. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 6753287 ↗