Resolute Onyx™ RONYX35034UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00643169557123), received between Jun 20, 2018 and May 17, 2022 — classified as 1 death, 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2022Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). 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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS STATED THAT AN ATTEMPT WAS MADE TO DELIVER THE STENT THROUGH A 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) AND WHEN THE DEVICE FAILED TO CROSS THE LESION IT WAS REMOVED AND NOTED TO BE DEFORMED ON THE PROXIMAL END OF THE STENT. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC STENT. THERE IS NO COMPLAINT ALLEGATION AGAINST THE TELESCOPE GEC. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14424948 ↗
• MalfunctionNov 26, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 75% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THELESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT COULD NOT BE DELIVERED TO THE LESION DUE TO THE CALCIFICATION PRESENT AND WHEN ATTEMPTING TO REMOVE THE STENT THROUGH A NON-MEDTRONIC 5.5 GUIDE EXTENSION CATHETER, STENT DISLODGEMENT OCCURRED. THE DISLODGED STENT WAS IN THE DISTAL END OF THE GUIDE CATHETER AND WAS PULLED BACK INTO THE GUIDE CATHETER USING THE STENT DELIVERY BALLOON. THE LESION WAS THEN FURTHER DILATED USING A 2.5X15MM BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12877246 ↗
• InjuryApr 22, 2021Device 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. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11708282 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE CX. DURING A STAGED PROCEDURE, ONE RESOLUTE ONYX WAS IMPLANTED IN THE R-PDA. APPROXIMATELY 23 MONTHS POST INDEX PROCEDURE AND 22 MONTHS POST STAGED PROCEDURE, PATIENT SUFFERED FROM CHRONIC TOTAL ARTERY OCCLUSION. EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion; Unspecified Tissue Injury

  MAUDE report 11257238 ↗
• MalfunctionJan 15, 2021Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A LESION LOCATED IN THE MID LEFT MAIN (LM) CORONARY ARTERY AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENTDEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING TWO MORE RESOLUTE ONYX STENTS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11177305 ↗
• MalfunctionJan 15, 2021Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A LESION LOCATED IN THE MID LEFT MAIN (LM) CORONARY ARTERY AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENTDEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING TWO MORE RESOLUTE ONYX STENTS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11177287 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, FOUR RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED; TWO IN THE RCA AND TWO IN GRAFT 1ST OBTUSE MARGINAL. APPROXIMATELY 9 MONTHS POST PROCEDURE, PATIENT SUFFERED ACUTE CORONARY SYNDROME AND WAS TREATED WITH MEDICATION. THE EVENT IS REPORTED TO BE RELATED TO MYOCARDIAL INFARCTION OF A NON TARGET VESSEL. PATIENT RECOVERED. CEC ADJUDICATED EVENT A NON-Q WAVE MI OF UNKNOWN VESSEL, 3RD UDMI SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 9864771 ↗
• DeathFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDEX PROCEDURE WAS PROMPTED MY MI AND SILENT ISCHEMIA. DURING INDEX PROCEDURE, A RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED IN THE RCA. APPROXIMATELY 10 MONTHS POST PROCEDURE, PATIENT SUFFERED CARDIOVASCULAR ACCIDENT (STROKE). SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Death; Stroke/CVA

  MAUDE report 9699099 ↗
• InjuryJan 29, 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 RCA. APPROXIMATELY ONE MONTH POST PROCEDURE, PATIENT SUFFERED HYPERTENSIVE CRISIS AND WAS TREATED WITH MEDICATION. PATIENT RECOVERED. CEC ADJUDICATED THE EVENT AN NON-Q WAVE MI 3RD UDMI SPONTANEOUS OF THE TARGET VESSEL. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 9640977 ↗
• MalfunctionNov 21, 2019Device 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 PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED, AND NEGATIVE PREP WAS CARRIED OUT PRIOR TO USE WITH NO ISSUES NOTED. NO RESISTANCE WAS NOTED WHEN ADVANCING THE DEVICE AND NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT WHEN THE STENT WAS ABOUT TO BE DEPLOYED THE STENT MOVED. IT WAS THOUGHT THE DEVICE EITHER MOVED OR FORESHORTENED MORE THAN WOULD HAVE BEEN EXPECTED. AS A RESULT THE PROXIMAL PART OF THE LESION WAS MISSED BY A FEW MM. IT WAS DECIDED NOT TO USE AN ADDITIONAL STENT TO TREAT THE MISSED SECTION OF THE LESION. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9353215 ↗
• MalfunctionJul 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. 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 DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE STENT DISLODGED INSIDE THE GUIDE CATHETER AND WAS REMOVED FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8757082 ↗
• InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDEX PROCEDURE WAS PROMPTED BY STABLE ANGINA. DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE RCA. 7 DAYS POST INDEX PROCEDURE THE PATIENT SUFFERED GI BLEEDING. THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION. SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO ANTI-PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 8645701 ↗
• MalfunctionOct 23, 2018Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT A BALLOON BURST OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7994152 ↗
• InjuryJun 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX RX DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A LESION IN THE RCA. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT THE STENT DISLODGED DURING DELIVERY TO THE LESION. IT IS REPORTED THAT THE DISLODGED STENT WAS REMOVED WITH A SNARE. NO PATIENT INJURY IS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7619362 ↗