Onyx Frontier™ ONYXNG50012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000511784), received between Nov 11, 2022 and May 13, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL LEFT MAIN (LM) CORONARY ARTERY. 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 WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED ANOTHER SAME SIZE ONYX FRONTIER STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305513 ↗
• MalfunctionJul 10, 2023Difficult to Insert; Device Damaged by Another Device; Material Deformation; Difficult to Insert; Device Damaged by Another Device; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) AND TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS (DES) TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 75% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE TELESCOPE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY OF THE TELESCOPE DEVICE. NEGATIVE PREP WAS PERFORMED ON BOTH ONYX FRONTIER STENTS WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE 5.00MM DIAMETER ONYX FRONTIER STENTS COULD NOT PASS OUT THROUGH THE DISTAL END OF THE TELESCOPE GEC. IT WAS DETAILED THAT BOTH STENTS WERE DAMAGED. A 4.5MM STENT WAS ABLE TO PASS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287009 ↗
• MalfunctionNov 11, 2022Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE OSTIUM RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY AT THE LESION. THE STENT WAS DEPLOYED IN THE OSTIAL RCA. A NON-MEDTRONIC BALLOON WAS USED TO POST DILATE THE STENT, HOWEVER, THE STENT DISLODGED AFTER USE OF THE BALLOON. THE DISLODGED STENT WAS NOT FOUND AND WAS NOT REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15778506 ↗