Resolute Onyx™ RONYX50015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169557307), received between May 22, 2018 and Oct 22, 2021 — classified as 1 death, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 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 19 MONTHS POST PROCEDURE PATIENT SUFFERED FROM A PULMONARY EMBOLISM. THE EVENT WAS TREATED WITH MEDICATION. PATIENT HAS NOT RECOVERED.

  Patient problems: Embolism/Embolus

  MAUDE report 12680536 ↗
• MalfunctionJan 6, 2021Inflation Problem; Inflation Problem

  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 INFLATION DIFFICULTIES OCCURRED WHEN THE STENT WAS PLACED IN THE PATIENT AND THE BALLOON WOULD NOT INFLATE. AN ATTEMPT WAS MADE TO USE A NEW INFLATION DEVICE BUT THIS DID NOT INFLATE THE DEVICE. THE STENT WAS REMOVED AND ANOTHER STENT WAS USED WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11122531 ↗
• DeathSep 28, 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 RCA. APPROXIMATELY 21 MONTHS POST PROCEDURE, PATIENT EXPIRED. SPONSOR ASSESSMENT OF EVENT IS UNKNOWN.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 10592032 ↗
• 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 RCA (TARGET VESSEL).

  Patient problems: Myocardial Infarction

  MAUDE report 10486901 ↗
• InjuryFeb 20, 2020Fracture; Fracture

  A RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT WAS IMPLANTED DURING A PROCEDURE. IT IS REPORTED THAT THE STENT FRACTURED, WHICH REQUIRED REPEAT CATHETERISATION AND NEW STENT PLACEMENT.

  Patient problems: Injury

  MAUDE report 9732030 ↗
• InjuryAug 19, 2019Malposition of Device; Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION IN THE FIRST OBTUSE MARGINAL ARTERY. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE LEFT CIRCUMFLEX CAME OFF AT A 90 DEGREE ANGLE FROM A SHORT LEFT MAIN. IT WAS REPORTED THAT WHILE ATTEMPTING TO ADVANCE THE STENT, THE PROXIMAL STENT WAS MOVING IN AND OUT OF THE 6F GUIDE CATHETER AND THE STENT DISLODGED. THE STENT WAS NOT REMOVED. IT WAS DEPLOYED IN THE PROXIMAL LEFT CIRCUMFLEX WITH A 3.5 X 15 BALLOON, THEN POST DILATED WITH A 4.0 AND 5.0 BALLOON. THE PATIENT IS ALIVE WITH NO OTHER INJURY.

  Patient problems: Injury

  MAUDE report 8905347 ↗
• InjuryMay 22, 2018Inflation Problem; Leak/Splash; Activation, Positioning or Separation Problem; Inflation Problem; Leak/Splash; Activation, Positioning or Separation Problem

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND NON-CALCIFIED LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THERE WERE NO ABNORMALITIES IN RELATION TO THE ANATOMY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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. IT WAS REPORTED THAT THE BALLOON ONLY HALF DEPLOYED AT NOMINAL PRESSURE (12 ATM) AND AFTER THE BALLOON WAS REMOVED IT WAS NOTED THAT THE STENT ONLY HALF DEPLOYED. THE INFLATION DIFFICULTY WAS NOT DUE TO DUE THE VESSEL MORPHOLOGY. THE SAME INFLATION DEVICE WAS USED WITH OTHER DEVICES PRE AND POST INFLATION DIFFICULTIES. IT WAS REPORTED THAT MULTIPLE NC EUPHORA BALLOON CATHETER DEVICES WERE USED TO FINISH DEPLOYING THE STENT. IT IS ALSO REPORTED THAT MULTIPLE SIZES OF THE NC EUPHORA BALLOON CATHETER WERE UNABLE TO CROSS THE LESION. PATIENT STATUS IS ALI

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7532528 ↗