Onyx Frontier™ ONYXNG25022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00763000511319), received between Aug 2, 2022 and Feb 19, 2026 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE STENT WAS ADVANCED THROUGH THE LESION. THE DISTAL EDGE OF THE SENT CRIMPED DUE TO UNDER-PREPPING OF THE CULPRIT AREA AS A RESULT OF HEAVILY CALCIFICATION. THE STENT BALLOON WAS NOT INFLATED. THERE WAS NO STENT LOSS. UPON EXAMINATION OF THE STENT OUTSIDE OF THE PATIENT'S BODY, THE ABNORMALITY WAS NOTED. THE STENT WAS SAFELY REMOVED AND A NEW STENT WAS USED. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24386973 ↗
• MalfunctionDec 2, 2025Difficult to Insert; Difficult to Advance; Material Deformation; Positioning Problem; Difficult to Insert; Difficult to Advance; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT FAILED TO CROSS THE LESION AND A STENT STRUT LIFTED UP. AN ATTEMPT WAS MADE TO ADVANCE THE STENT IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA) BUT WAS UNSUCCESSFUL. IT WAS ALSO REPORTED THAT SOME RESISTANCE WAS NOTED WHEN PUTTING THE STENT ON THE WIRE BUT THE DEVICE STILL WENT ON THE WIRE. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, MILDLY CALCIFIED WITH 99% STENOSIS IN THE DISTAL RCA. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 DURING DELIVERY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23693441 ↗
• InjurySep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT DISLODGED DURING DELIVERY TO OR AT THE LESION IN THE CIRCUMFLEX ARTERY. THE STENT WAS NOT DEPLOYED. THE STENT WAS NOT ABLE TO BE REMOVED VIA A SNARE OR OTHER TECHNIQUE. AS AN INTERVENTION, THE STENT WAS CRUSHED AGAINST THE ARTERIAL WALL. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION BEING TREATED WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. THERE WAS NO INJURY TO THE PATIENT. THE PATIENT WAS DISCHARGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991975 ↗
• MalfunctionJul 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DEFORMATION OCCURRED WITH THE ONYX FRONTIER STENT IN VIVO DURING POSITIONING. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED, AND NEGATIVE PREPARATION WAS PERFORMED WITHOUT PROBLEMS. THE PROCEDURE WAS COMPLETED WITH A NEW ONYX FRONTIER STENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564337 ↗
• MalfunctionJun 5, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT BENT WHILE CROSSING THE LESION, AND A STENT STRUT BROKE OFF DURING DELIVERY THROUGH THE VESSEL. THE LESION BEING TREATED WAS SEVERELY TORTUOUS AND SEVERELY CALCIFIED. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. TWO OTHER ONYX STENTS WERE USED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22148599 ↗
• InjuryMar 28, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING DELIVERY AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED AND WAS DEPLOYED IN THE LESION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718001 ↗
• InjuryFeb 21, 2025Entrapment of Device; Difficult to Remove; Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Entrapment of Device; Difficult to Remove; Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING DELIVERY TO/AT THE LESION. THE STENT WAS BEING USED WITH ONE TELESCOPE GUIDE EXTENSION CATHETER WHEN THE STENT CAME OFF THE DELIVERY SYSTEM. THERE WAS DAMAGE TO THE STENT DEVICE. THE DISLODGED STENT WAS NOT REMOVED. THE PATIENT WENT TO SURGERY TO OPEN THE SHUT DOWN VESSEL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; Obstruction/Occlusion; Vascular Dissection

  MAUDE report 21431716 ↗
• MalfunctionJan 2, 2025Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT IN THE PROXIMAL SECTION OF THE CIRCUMFLEX ARTERY. THE ARTERY HAD MILD TORTUOSITY AND CALCIFICATION. THE STENT WAS DEPLOYED, HOWEVER, A STRUT ON THE CATHETER WAS BENT AND STICKING OUT, WHICH PREVENTED THE STENT FROM BEING PULLED BACK THROUGH THE DELIVERY SYSTEM. THE PROCEDURE WAS NOT COMPLETED. THE STENT WAS REMOVED FROM THE PATIENT. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE-DILATED, AND THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, NOR WAS EXCESSIVE FORCE USED DURING DELIVERY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21053038 ↗
• InjuryJul 5, 2024Difficult to Remove; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Difficult to Remove; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A 1.5MM AND 2.0MM BALLOON. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, WHICH CROSSED OVER THE DIAGONAL. THE PREVIOUSLY DEPLOYED STENT WAS IMPLANTED IN 2013. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. AFTER THE FIRST PRE-DILATION, AN ATTEMPT WAS MADE TO THE DELIVER THE ONYX FRONTIER STENT, WHICH WAS UNSUCCESSFUL. THE STENT WAS REMOVED SUCCESSFULLY, AND THE LESION WAS FURTHER PRE-DILATED WITH A 2.5MM NON-COMPLIANT BALLOON. ANOTHER ATTEMPT WAS MADE TO DELIVER THE STENT, BUT THIS WAS ALSO UNSUCCESSFUL. AN ATTEMPT WAS THEN MADE TO TRY AND REMOVE THE STENT, BUT THE STENT DISLODGED. IT IS BELIEVED THAT THE STENT MAY HAVE CAUGHT ON A STRUT OF THE OLD STENT THAT WAS ACROSS THE OSTIUM OF THE DIAGONAL. AN

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

  MAUDE report 19678314 ↗
• MalfunctionMay 21, 2024Inflation Problem; Inflation Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED. IT WAS DETAILED THAT THE STENT DID NOT DEPLOY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19358907 ↗
• InjuryMay 2, 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. THE DEVICE WAS INSPECTED WITH NO ISSUES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED. THE STENT WAS CRUSHED INTO THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 19228159 ↗
• MalfunctionApr 15, 2024Entrapment of Device; Device Dislodged or Dislocated; Entrapment of Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 70% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS DETAILED THAT THE STENT BALLOON WAS INFLATED TO NOMINAL PRESSURE, BUT THE STENT WAS NOT VISIBLE DURING BALLOON INFLATION. THE STENT WAS BEING DELIVERED THROUGH A 6F NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC). IT WAS BELIEVED THAT THE STENT GOT HUNG UP AND COME OFF IN THE GEC OR THE 6F NON-MEDTRONIC SHEATH. WHEN THE BALLOON WAS REMOVED THE STENT CAME OUT WITH THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SAME SIZE ONYX FRONTIER STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103426 ↗
• InjuryFeb 20, 2024Entrapment of Device; Device Dislodged or Dislocated; Positioning Problem; Entrapment of Device; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED. IT WAS DETAILED THAT THE STENT WOULD NOT CROSS THE DISTAL RCA LESION AFTER SIGNIFICANT PRE-DILATION. UPON RETRIEVAL OF THE UNDEPLOYED STENT, THE STENT BECAME STUCK IN THE MID RCA AND WOULD NOT RETRACT ANY FURTHER. IT WAS NOTED THAT THE STENT WAS BEGINNING TO PARTIALLY SLIDE OFF THE BALLOON. BEFORE THE STENT DISLODGED FULLY FROM THE BALLOON, THE BALLOON WAS PLACED INSIDE THE STENT AND THE STENT WAS DEPLOYED SAFELY. THE STENT WAS POST DILATED WITH A 3.5MM NC BALLOON. ANOTHER STENT WAS NOT ADVANCED TO THE DISTAL AREA SINCE THE VESSEL HAD TIMI3 FLOW. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 18737024 ↗
• MalfunctionJan 30, 2024Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS NOT INSPECTED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING INSERTION INTO THE HOMEOSTATIC VALVE. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18610950 ↗
• MalfunctionMar 3, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL DIAGONAL BRANCH. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE CATHETER/SHAFT FRACTURED DURING DELIVERY THROUGH THE VESSEL. IT WAS STATED THAT THE CATHETER FRACTURED OUTSIDE OF THE BODY. THE DETACHED PORTION OF THE DEVICE DOES NOT REMAIN IN THE PATIENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477147 ↗
• MalfunctionMar 1, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE DISTAL RIGHT CORONARY (RCA) 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 DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.5 X 22MM ONYX FRONTIER STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460358 ↗
• MalfunctionNov 16, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) ARTERY WITH 80% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803340 ↗
• InjuryOct 25, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID OBTUSE MARGINAL (OM) ARTERY. THERE WAS MODERATE IN-STENT RESTENOSIS (ISR) IN A PREVIOUSLY PLACED OM STENT WITH NO FLOW LIMITING STENOSIS IN THE LEFT MAIN (LM). A RECENTLY PLACED STENT IN THE LMCA AND THE OSTIAL LEFT CIRCUMFLEX (LCX) WAS WIDELY PATENT. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A 2.5 MM BALLOON, BUT THERE WAS DIFFICULTY DELIVERING AN IVUS BEYOND THE LM DUE TO ANGULATION OF THE GUIDE, AND EXTENSION OF THE NEW STENT INTO THE AORTA BY A FEW MM. HOWEVER, THE LM STENT WAS PATENT WITH GOOD EXPANSION AND APPOSITION. THE DIFFICULTY IN ADVANCING EQUIPMENT WAS DUE TO THE SEVERE ANGULATION OF THE OSTIAL LCX AND GETTING CAUGHT ON PRIOR STENT STRUTS. A 2.5 MM NC BALLOON WAS USED TO FURTHER PREDILATE THE OM AND ALSO TO ADVANCE A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) INTO THE PROXIMAL LCX. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FO

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

  MAUDE report 15666247 ↗
• MalfunctionOct 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING CHRONIC TOTAL OCCLUSION 100% (CTO) LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT A 5F NON-MEDTRONIC (MDT) GUIDE EXTENSION CATHETER (GEC) WAS USED TO ACCESS THE LESION THROUGH A LAUNCHER GUIDE CATHETER. THE STENT COULD NOT BE DELIVERED. UPON REMOVAL OF THE STENT, THE STENT DISLODGED FROM THE BALLOON INSIDE THE NON-MDT GEC. THE DISLODGED STENT WAS REMOVED AS IT WAS TRAPPED IN THENON-MDT GEC. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15585619 ↗
• InjuryAug 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID, DISTAL AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT AFTER THE ONYXNG25018UX WAS PLACED IN THE PROXIMAL VESSEL AT 12 ATM, A DISTAL EDGE DISSECTION OCCURRED. A SECOND DEVICE, THE ONYXNG25022UX (PLI20), WAS USED TO TREAT THE DISTAL EDGE DISSECTION. A VISIBLE HYPERACUTE THROMBUS WAS OBSERVED IN THE PROXIMAL ASPECT OF ONYXNG25018UX. WITHIN 5-8 MINUTES THE THROMBUS WAS VISUALIZED, ONLY AFTER COVERING THE DISTAL EDGE WITH THE ONYXNG25022UX. A NC EUPHORA CORONARY BALLOON WAS THEN USED TO POST DILATE THE ENTIRE STENT LENGTH AT 15/18 ATM. THERE WAS NO ISSUES NOTED DURING STENT DEPLOYMENT. THE ONYXNG25018UX WAS FULLY EXPANDED. THE PATIENT WAS ON HEPARIN AND INTEGRILLIN, AND AT THE END OF THE CASE WAS GIVEN TICAGRELOR. T

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 15154709 ↗
• MalfunctionAug 2, 2022Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THERE WAS DAMAGE NOTED TO THE PACKAGING. THERE WERE ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH ISSUES NOTED. 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 DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION IN VIVO OCCURRED DURING POSITIONING/ADVANCEMENT. THE STENT FAILED TO CROSS AND WHEN IT WAS REMOVED FROM THE GUIDE CATHETER, THE STENT STRUT WAS NOTED TO BE FLARED. IT WAS ALSO REPORTED THAT WHEN REMOVING THE STENT SYSTEM FROM THE HOOP, THE END OF THE HOOP CAME OFF. IT WAS STATED THAT THERE WAS A LOT OF DISEASE. ANOTHER ONYX FRONTIER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15146780 ↗