Resolute Onyx™ RONYX22518WRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169602243), received between Nov 10, 2017 and Nov 10, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2017Material Deformation; Material Deformation

  THE PHYSICIAN WAS INTENDING ON USING A RESOLUTE ONYX DRUG ELUTING STENT IN A PATIENT'S HEAVILY CALCIFIED AND VERY TORTUOUS PROXIMAL CIRCUMFLEX LESION WITH 95% STENOSIS. NO DAMAGE WAS NOTED TO THE PACKAGING AND THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED AND THE LESION WAS PRE-DILATED WITH A 2.5 BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION IN VIVO DURING POSITIONING OCCURRED. THE PHYSICIAN ATTEMPTED MULTIPLE TIMES TO POSITION THE STENT IN THE LESION. UPON REMOVAL OF THE DEVICE, THE PHYSICIAN NOTED THAT A STRUT WAS BENT OUT OF LINE. THE LESION WAS PREDILATED WITH A 3.0 NC BALLOON AND A NEW RESOLUTE ONYX. STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE DAY AFTER THE PROCEDURE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7017669 ↗