Resolute Onyx™ RONYX50018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169557314), received between Sep 10, 2018 and Jul 13, 2021 — classified as 1 death, 3 injuries, 2 malfunctions.

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

• MalfunctionJul 13, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL LM/LAD ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS REPLACED WITH A SAME SIZED RESOLUTE ONYX. THE PATIENT IS ALIVE WITH NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12156852 ↗
• DeathJun 8, 2020Adverse 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 2ND OBTUSE MARGINAL. TWO DAYS LATER DURING A STAGED PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED; TWO IN THE RAMUS AND ONE IN THE LCMA. APPROXIMATELY 20 MONTHS LATER, THE PATIENT SUFFERED CARDIOGENIC SHOCK, SEVERE MITRAL REGURGITATION, WORSENING RENAL FAILURE AND DIED. DEATH WAS CLASSIFIED AS NON SUDDEN CARDIAC DEATH. INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10127343 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. ON THE SAME DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION . EVENT WAS TREATED WITH PCI. INVESTIGATOR ASSESSED THAT THE EVENT WAS UNLIKELY RELATED TO INDEX DEVICE AND NOT RELATED TO ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. CEC ADJUDICATED THE EVENT AS MI (TARGET VESSEL). CEC COMMENTED THAT THE FILM WAS REVIEWED AND OCCLUSION OF THE RV MARGINAL BRANCH WAS NOTED.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9847357 ↗
• InjuryApr 30, 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 TO TREAT THE RCA. APPROXIMATELY 6 DAYS POST INDEX PROCEDURE THE PATIENT SUFFERED ARM DISCOMFORT. IT WAS REPORTED THAT THE PATIENT MAY HAVE SUFFERED A POSSIBLE EMBOLIC EVENT. STROKE DID NOT OCCUR. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE PATIENT IS RECOVERING.

  Patient problems: Embolism; Stroke/CVA

  MAUDE report 8564659 ↗
• InjuryMar 8, 2019Fracture; Material Deformation; Fracture; Material Deformation

  DURING A PROCEDURE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO SUCCESSFULLY TREAT A NEAR OCCLUSION OF A NON-MEDTRONIC STENT PREVIOUSLY IMPLANTED IN THE LEFT PULMONARY ARTERY (LPA). DURING THE SAME PROCEDURE A TRANSCATHETER PULMONARY BIO PROSTHETIC VALVE (MELODY VALVE) WAS IMPLANTED. POST IMPLANTATION OF THE MELODY VALVE THE RESOLUTE ONYX STENT WAS NOTED TO HAVE BECOME COMPRESSED AND FRACTURED THEREFORE THE STENT WAS RE-CROSSED AND RE-BALLOONED USING A 4.5 AND 5MM NC BALLOON AT A HIGH PRESSURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8403446 ↗
• MalfunctionSep 10, 2018Burst Container or Vessel; Inflation Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Burst Container or Vessel; Inflation Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED IN THE MID RCA. THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT DURING POSITIONING THE STENT CATHETER WAS SEVERELY KINKED AND WHEN AN ATTEMPT WAS MADE TO DEPLOY THE STENT INFLATION DIFFICULTIES WERE ENCOUNTERED DURING THE FIRST INFLATION. THE BALLOON WAS ONLY ABLE TO BE INFLATED TO 2 ATM REGARDLESS OF HOW MANY ATTEMPTS WERE MADE TO DELIVER MORE PRESSURE. THE PROXIMAL AND DISTAL PORTIONS OF THE STENT FLARED AT 2 ATM. IT WAS SUGGESTED THAT BALLOON BURST/LEAK OCCURRED. THE STENT WAS THEREFORE UNABLE TO BE DEPLOYED. THE WIRE, STENT AND GUIDER WERE THEN ALL REMOVED AT ONCE AND THE STENT WAS NOT ON THE BALLOON AFTER REMOVAL OF ALL PRODUCTS AND APPEARS TO HAVE D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7859185 ↗