Resolute Onyx™ RONYX35008UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169557055), received between Nov 16, 2017 and May 20, 2022 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2022Device 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 LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AFTER REMOVAL OF THE DEVICE FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14448039 ↗
• InjuryMar 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE OSTIUM OF THE CIRCUMFLEX (CX) ARTERY. IT WAS STATED THAT THE PATIENT WAS BROUGHT TO THE CATH LAB FOR INTERVENTION AS THEY HAD DECLINED UNDERGOING CARDIAC SURGERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. IT WAS STATED THAT A LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS STENTED EARLIER IN THE CASE. IT WAS REPORTED THAT THE RESOLUTE ONYX STENT MOVED BACKWARDS DURING DEPLOYMENT IN THE OSTIAL CX, WHICH LED TO THE PROXIMAL PORTION OF THE STENT BEING DEPLOYED IN THE DISTAL LEFT MAIN (LM). A TECHNIQUE INVOLVING A BALLOON WAS USED CRUSH DOWN THE PROXIMAL PORTION OF THE STENT THAT WAS LOCATED IN THE LM. A SMALL 1.5 MM BALLOON WAS USED TO OPEN A STRUT OF THE RESOLUTE ONYX IN THE CX, IN ORDER TO TREAT A LESION IN THE LAD. THE LAD WAS LATER STENTED DURING CASE. ANOTHER STENT WAS THEN DEPLOYED IN THE LM ARTERY AND A KISSING BALLOON TECHNIQUE WAS USED TO POS

  Patient problems: Insufficient Information

  MAUDE report 13755637 ↗
• InjuryJul 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION EXHIBITING 80% STENOSIS LOCATED IN THE OSTIUM CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. THE LESION WAS 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. IT WAS STATED THAT A 1.25X15 SPRINTER BALLOON WAS DELIVERED THROUGH THE DISLODGED STENT AND INFLATED, THEN A 2.0X12 EUPHORA SC AND A 3.5X12 NC EUPHORA WERE INFLATED WITHIN THE DISLODGED STENT AND A 4.0X12 NC EUPHORA PTCA BALLOON CATHETER FINISHED DEPLOYING THE STENT AT THE DISLODGEMENT SITE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12149722 ↗
• InjuryJun 30, 2021Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT, ONE COUGAR GUIDEWIRE AND ONE 6F LAUNCHER GUIDE CATHETER TO TREAT A NON- TORTUOUS LESION IN THE PROXIMAL LM ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE COUGAR AND THE LAUNCHER WERE PREPPED PER (B)(4) WITH NO ISSUES. THE COUGAR WIRE TIP WAS FORMED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE RESOLUTE ONYX AND LAUNCHER DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THE COUGAR DEVICE DID PASS THROUGH THE DEPLOYED RESOLUTE ONYX. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A LAUNCHER WAS USED WITH A NON MEDTRONIC GUIDEWIRE TO DELIVER THE RESOLUTE ONYX TO THE LEFT MAIN. AFTER THE PROCEDURE WAS COMPLETED AND WIRE WAS REMOVED ANOTHER ANGIOGRAM WAS TAKEN. A NON MEDTRONIC OCT DEVICE WAS USED TO IMAGE THE STENT. USING THE LAUNCHER GUIDE CATHETER, THE COUGAR WIRE WAS USED TO CROSS THE NEWLY IMPLANTED STENT. NO ISSUES WERE NOTED. THE DEPLOYED RESOLUTE ONYX WAS CROSSED WITH A NON MEDTRONIC OCT IMAGING CATHETER. SOME RESISTANCE WAS NOTED AND DIFFICULT

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12092852 ↗
• MalfunctionMar 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE OYNX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE OSTIUM OF THE CIRCUMFLEX (CX) 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 THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. IT WAS STATED THAT THE STENT WAS REMOVED VIA THE BALLOON THROUGH THE GUIDE CATHETER. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11587806 ↗
• MalfunctionNov 9, 2020Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A NON-TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE DISTAL RCA. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS INDICATED THAT THE STENT GOT STUCK ON THE THIRD BALLOON WHEN RETRACTING DEFLATED BALLOON FROM THE PATIENT. THE DISLODGED STENT WAS REMOVED. NO PATIENT INJURY REPORTED.

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

  MAUDE report 10807936 ↗
• 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 9640967 ↗
• 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 8280834 ↗
• MalfunctionNov 22, 2018Fracture; Fracture

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT IS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND FRACTURED IN TWO. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8098603 ↗
• MalfunctionNov 15, 2018Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT LESION. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND STENT DEFORMATION OCCURRED. IT IS INDICATED THAT STENT DEFORMATION OCCURRED DUE TO CALCIFICATION OF THE TORTUOUS VESSEL. THE PROCEDURE WAS COMPLETED USING A NON-MDT STENT. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073098 ↗
• MalfunctionJun 7, 2018Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT BECAME DAMAGED/DEFECTIVE AND A STENT DISLODGEMENT OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7576855 ↗
• MalfunctionNov 16, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY EXHIBITING 80% STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING AND 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 DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE FIRST STENT TO BE USED, A 3.5X38MM RESOLUTE ONYX RX STENT, WAS DEPLOYED IN A DE NOVO LESION IN MID/DISTAL RCA. POST FIRST STENT PLACEMENT, THERE WAS A PERCEIVED EDGE DISSECTION. A 3.5X8MM RESOLUTE ONYX STENT WAS THEN ADVANCED THROUGH THE EXISTING STENT IN AN ATTEMPT TO TREAT THE PERCEIVED DISSECTION. DURING THE ADVANCEMENT RESISTANCE WAS NOTED AND MORE FORCE THAN USUAL WAS EXERTED TO ATTEMPT TO PASS THE STENT THROUGH THE EXISTING STENT. IT WAS REPORTED THAT WHEN THE STENT WAS WITHDRAWN, DEFORMATION OF THE STENT STRUTS WAS NOTED. A BALLOON WAS PASSED THROUGH THE STENT TO DILATE THE P

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7036356 ↗