Resolute Onyx™ RONYX45026UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169557277), received between Apr 17, 2018 and Aug 31, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS DETAILED THAT A PATIENT HAD A RESOLUTE ONYX DEVICE IMPLANTED. DURING A VISIT TO HER NEUROLOGIST THE PATIENTS ANTIPLATELET MEDICATION WAS CHANGED FROM BRILLINTA TO ANOTHER MEDICATION. AFTER ONE MONTH ON THE NEW MEDICATION THE PATIENT BECAME MORE TIRED AND HAD DIFFICULTY SAYING WORDS. THIS BEGAN TO DETERIORATE AND THE PATIENT WAS BROUGHT TO THE HOSPITAL AT WHICH TIME SHE HAD A HEADACHE AND DIZZINESS. AN MRI WAS PERFORMED AND MEDICATION WAS ADMINISTERED TO ELEVATE THE SYMPTOMS. IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A TIAS. IT WAS STATED THAT THE IMPLANTED RESOLUTE ONYX DEVICE HAD FAILED TO PREVENT CLOTTING AND HAD CAUSED NEARLY A COMPLETE BLOCKAGE AT THE ARTERY AND PUT HER AT RISK OF ANOTHER SEVERE STROKE. THE PATIENT WAS RETURNED TO THE ORIGINAL MEDICATION. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Embolism/Embolus; Insufficient Information; Ischemia; Obstruction/Occlusion; Stroke/CVA

  MAUDE report 15327073 ↗
• MalfunctionSep 29, 2021Fracture; Material Deformation; Fracture; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT WAS FRACTURED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12545736 ↗
• InjuryJan 4, 2021Adverse 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 RCA. APPROXIMATELY 25.5 MONTHS LATER THE PATIENT SUFFERED GI BLEED. THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT. THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION. THE EVENT WAS TREATED WITH A CHANGE OF MEDICATION AND THE PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11108402 ↗
• InjuryAug 27, 2020Adverse 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. CEC ADJUDICATED TARGET VESSEL MI.

  Patient problems: Myocardial Infarction

  MAUDE report 10458813 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE A PATIENT HAD ONE RESOLUTE ONYX RX STENT IMPLANTED. ONE DAY POST INDEX PROCEDURE THE PATIENT SUFFERED A CEC NON Q WAVE MI. THERE WAS NO IMPACT TO THE PATIENT. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED TO PREVENT PERMANENT INJURY OR IMPAIRMENT. THE INVESTIGATOR, SPONSOR AND CEC ASSESSED THE EVENT AS NOT RELATED TO THE PRODUCT OR THERAPY.

  Patient problems: Myocardial Infarction

  MAUDE report 10447136 ↗
• InjuryOct 31, 2019Adverse 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 RCA AND THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE LAD DURING STAGED PROCEDURE. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM ATYPICAL CHEST PAIN. EVENT WAS TREATED WITH MEDICATION. CEC AND SAFETY ADJUDICATED THE EVENT AS NON-Q-WAVE MI, 3RD UDMI SPONTANEOUS(VESSEL UNKNOWN). INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9260173 ↗
• InjuryApr 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 95% STENOSIS IN THE MID RCA. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. NO DIFFICULTIES WERE NOTED WHEN LOADING THE DEVICE ONTO THE GUIDEWIRE. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE STENT MET RESISTANCE AT THE DISTAL PART OF THE LESION AND AS THE DOCTOR PULLED BACK THE STENT THE NON-MDT GUIDE BACKED OUT INTO A NON COAXIAL POSITION. THE GUIDE WENT BACK INTO THE AORTA AND PULLED THE STENT BACK AND THE PROXIMAL EDGE OF THE STENT CAUGHT THE NON COAXIAL TIP OF THE GUIDE CATHETER AND KNOCKED THE STENT OFF. 3/4 OF THE STENT BALLOON WAS STILL IN THE STENT SO THE PHYSICIAN INFLATED THE BALLOON. THE DISPLACED DISLODGED STENT WAS DEPLOYE

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7435538 ↗