Onyx Frontier™ ONYXNG30008UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000511456), received between Jan 27, 2023 and Dec 11, 2024 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 11, 2024Deformation Due to Compressive Stress; Device Damaged by Another Device; Device Dislodged or Dislocated; Deformation Due to Compressive Stress; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING DELIVERY TO/AT THE LESION. THE STENT DISLODGED WHEN USED WITH A NON-MEDTRONIC GUIDE EXTENSION CATHETER. THE DISLODGED STENT WAS NOT REMOVED. A SMALL BALLOON WAS INSERTED THROUGH THE DISLODGED STENT TO DEPLOY THE STENT. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 20901311 ↗
• InjuryDec 6, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED IN THE VESSEL. THE CASE WAS DIFFICULT AND COMPLEX. THE STENT WAS SUCCESSFULLY SNARED OUT. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20862388 ↗
• InjuryOct 25, 2024Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY CALCIFIED LESION IN THE LEFT MAIN (LM) CORONARY ARTERY AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS DETAILED THAT THE LM WAS ENGAGED WITH AN EBU 3.75 GUIDE AND WAS WIRED WITH A NON-MEDTRONIC (MDT) WIRE WITH SOME DIFFICULTY. THE LESION WAS PRE-DILATED WITH A 2.75MM BALLOON. THE LESION WAS THEN STENTED WITH A 3.0X8MM DES AT 16 ATM. THERE WAS A PROXIMAL EDGE DISSECTION. THE ONYX FRONTIER STENT WAS BEING USED TO COVER THE DISSECTION, BUT THE STENT WAS UNABLE TO PASS DUE TO CALCIUM IN THE PROXIMAL LAD AND LM. A TELESCOPE GUIDE EXTENSION CATHETER (GEC) WAS USED TO ASSIST IN PASSING THE STENT, BUT THE STENT DISLODGED FROM THE BALLOON VERY EASILY, LIKELY DUE TO STENT MALFUNCTION, AND WAS FLOATING IN THE PROXIMAL LAD AND LM. AN ATTEMPT WAS MADE TO SNARE THE STENT WITH A 2.0MM BALLOON DEPLOYED WITHIN THE STENT TO TRY PULL IT INTO THE GUIDE, HOWEVER THE STENT WOULD NOT COME INTO THE GUIDE. A DECISION WAS MADE TO DEPLOY THE STENT. DUE TO TELESCO

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 20531556 ↗
• InjurySep 3, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A TORTUOUS AND HEAVILY CALCIFIED LESION IN THE OSTIAL LEFT CIRCUMFLEX (LCX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. STENT PREPARATION WAS NORMAL, AND WITHOUT PULLING NEGATIVE ON THE BALLOON AT ANY TIME. IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE ADVANCED TO THE TARGET LESION DUE TO VESSEL TORTUOSITY AND HEAVY CALCIFICATION. ON ATTEMPTING TO PULL THE STENT BACK INTO THE NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC), THE UNDEPLOYED STENT BECAME DISLODGED FROM THE STENT BALLOON. IT WAS NOT POSSIBLE TO ADVANCE THE GEC OVER THE STENT; HOWEVER, IT WAS POSSIBLE TO ADVANCE A NEW 2.0MM BALLOON OVER THE WIRE AND THROUGH AND PAST THE STENT, TO ACHIEVE STENT RETRIEVAL TO THE RADIAL ARTERY SHEATH LOCATION. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 20123264 ↗
• InjuryJan 17, 2024Positioning Problem; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT (DES) TO TREAT A LESION. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION. A VESSEL DISSECTION WAS REPORTED.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 18523987 ↗
• MalfunctionDec 18, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS INTENDED TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE SHEATH WAS REMOVED PER IFU. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE CATHETER/DELIVERY SYSTEM WAS DEFORMED, AND THE STENT WAS NOT USED. THE DELIVERY SHAFT WAS FOUND TO BE BROKEN WHEN OPENING THE PACKAGING OF THE DEVICE. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18342853 ↗
• MalfunctionJan 27, 2023Entrapment of Device; Device Dislodged or Dislocated; Material Deformation; Entrapment of Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT AND ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A LESION. THE ONYX FRONTIER STENT WAS INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE GEC WAS NOT INSPECTED. THE TELESCOPE GEC WAS PREPPED PER IFU WITH NO ISSUES NOTED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT AND THE STENT DISLODGED INSIDE THE TELESCOPE LUMEN. IT WAS STATED THAT THE STENT CAME OFF THE DELIVERY SYSTEM AND BECAME STUCK INSIDE THE TELESCOPE LUMEN. IT WAS BELIEVED THE STENT STRUT FLARED WHICH RESULTED IN THE STENT GETTING STUCK IN THE TELESCOPE GEC. THE PROCEDURE WAS COMPLETED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252755 ↗