Onyx Frontier™ ONYXNG27538UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000511449), received between Nov 1, 2022 and Aug 26, 2024 — classified as 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2024Deformation Due to Compressive Stress; Material Deformation; Positioning Problem; Deformation Due to Compressive Stress; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED. DELIVERY OF THE STENT WAS ATTEMPTED BUT WAS NOT POSSIBLE DUE TO THE CALCIFICATION. THE STENT WAS REMOVED AND IT WAS FOUND THAT A STENT STRUT HAD FRAYED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063503 ↗
• InjuryApr 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED IN VIVO DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS REMOVED USING A SNARE. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19031398 ↗
• MalfunctionFeb 13, 2024Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS DETAILED THAT AS THE STENT WAS ATTEMPTED TO BE ADVANCED, RESISTANCE WAS FELT. UPON REMOVAL OF THE STENT, IT WAS NOTED TO BE DEFORMED. THE PROCEDURE WAS COMPLETED WITH A 2.75 X 38MM NON-MEDTRONIC STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18693106 ↗
• InjuryFeb 8, 2024Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS DETAILED THAT THE STENT APPEARED TO GET STRIPPED OFF AS IT WAS BEING RETRIEVED BACK INTO THE GUIDE CATHETER AFTER IT FAILED TO CROSS THE LESION. THE DISLODGED STENT WAS REMOVED WITH A SNARE AS IT DISLODGED HALFWAY IN THE VESSEL AND THE GUIDE CATHETER. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18672360 ↗
• InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 85% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE LEFT ANTERIOR DESCENDING (LAD) WAS PERFORATED POST STENT DEPLOYMENT. IT WAS DETAILED THAT A 3.0X38MM ONYX FRONTIER STENT WAS DEPLOYED IN THE MID LAD. A DECISION WAS THEN MADE TO STENT DISTAL TO THE MID LAD. THE 2.75 X 38MM ONYX FRONTIER DEVICE WAS EASILY PLACED DISTALLY AND DEPLOYED. NO POST DILATION BALLOON WAS USED. A DISTAL PERFORATION OCCURRED, AND A 2.5 X 15MM BALLOON WAS USED TO SEAL OFF THE PERFORATION THE PATIENT IS REPOR TED TO BE ALIVE WITH NO INJURY.

  Patient problems: Perforation

  MAUDE report 15706377 ↗