Onyx Frontier™ ONYXNG25015UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000511296), received between Sep 2, 2022 and Feb 18, 2026 — classified as 2 deaths, 11 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Entrapment of Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE TARGET LESION WAS LOCATED IN THE MID OBTUSE MARGINAL (OM) ARTERY WHICH EXHIBITED SEVERE TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED, BOTH WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED PRIOR TO THE ATTEMPTED STENT DELIVERY. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE DISLODGED STENT WAS REMOVED WHEN THE GUIDE EXTENSION CATHETER WAS WITHDRAWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376493 ↗
• MalfunctionDec 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE CATHETER SHAFT DETACHED. THE STENT WAS SUCCESSFULLY DEPLOYED IN THE PATIENT, HOWEVER UPON REMOVING THE DELIVERY SYSTEM FROM THE PATIENT, THE BALLOON RAIL BROKE AT THE SECTION WHERE THE SHAFT IS JOINED TO THE BALLOON RAIL. THE RAIL BROKE WHEN REMOVING THE GUIDE AND SYSTEM FROM THE SHEATH. NO PIECES WERE RETAINED IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757310 ↗
• MalfunctionOct 29, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT (DES), POSITIONING DIFFICULTIES WERE ENCOUNTERED AND STENT DEFORMATION OCCURRED DURING POSITIONING/ADVANCEMENT. STENT STRUT WAS BENT UPON ATTEMPTING TO ADVANCE THE DEVICE IN THE LESION. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION BEING TREATED WA S LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411283 ↗
• InjuryOct 17, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING DELIVERY OF ONE ONYX FRONTIER STENT TO THE LESION, THE STENT BECAME DISLODGED AND WAS WEDGED IN A CALCIFIED VESSEL. THE DEVICE WOULD NOT CROSS THE LESION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) EXHIBITING 99% STENOSIS. AN ADDITIONAL WIRE WAS DELIVERED PAST THE STENT TO TRAP THE DISLODGED STENT BEHIND TWO OVERLAPPING SHORTER STENTS. IT WAS INDICATED THAT THE STENT WAS WEDGED IN CALCIUM WHICH CONTRIBUTED TO THE DISLODGEMENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED ACCORDING TO IFU, WITH NO ISSUES NOTED. THE LESION WAS PRE DILATED WITH 2.0X12MM COMPLIANT AND A 2.5X12MM NONCOMPLIANT BALLOONS. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT OR CELL OF A STENT. EXCESSIVE FORCE WAS NOT USED. THE STENT WAS NOT REMOVED FROM THE PATIENT. 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 23328668 ↗
• MalfunctionAug 4, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DELIVERY OF THE ONYX FRONTIER STENT TO A LESION IN THE LEFT MAIN AND CIRCUMFLEX ARTERIES AT THE OSTIUM AND PROXIMAL LOCATIONS, THE STENT BECAME DISLODGED WHILE PASSING THROUGH THE STRUTS OF ANOTHER PREVIOUSLY-DEPLOYED STENT IN THE PLAD AND LEFT MAIN ARTERY. THE DISLODGED STENT WAS NOT REMOVED AND REMAINS IN THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NOISSUES FOUND, AND THE LESION WAS PRE-DILATED. NEGATIVE PREP WAS NOT PERFORMED.  RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT, BUT NO EXCESSIVE FORCE WAS USED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THE STENT WAS SLOWLY INFLATED BECAUSE A WIRE REMAINED IN PLACE. NO 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 22709285 ↗
• InjuryMay 21, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE DELIVERY OF ONE ONYX FRONTIER DRUG ELUTING STENT TO THE SEVERELY CALCIFIED PROXIMAL CIRCUMFLEX (CX) ARTERY, STENT DISLODGEMENT OCCURRED. THE DEVICE WAS NOT INSPECTED PRIOR TO USE. NEGATIVE PREP WAS NOT PERFORMED. THE STENT DISLODGED WHILE BEING ADVANCED TO THE TARGET LESION. THE NON-MEDTRONIC CATHETER CLIPPED A STENT STRUT. IT IS UNCLEAR WHETHER THE DEVICE WAS TRAVERSING A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE DEVICE, AND EXCESSIVE FORCE WAS USED DURING DELIVERY. THE STENT CAME OFF THE DELIVERY SYSTEM, AND A SMALLER BALLOON WAS USED TO POSITIONED IN A LESS IDEAL POSITION. THE STENT WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22067160 ↗
• InjuryMay 9, 2025Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED. THE LESION BEING TREATED WAS SEVERELY TORTUOUS, SEVERELY CALCIFIED WITH 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE STENT DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY ATTEMPT. THE STENT BECAME LODGED IN THE MID LAD AND WAS NOT REMOVED. ATTEMPTS TO RECROSS THE DISLODGED STENT WITH A BALLOON WERE UNSUCCESSFUL. THE STENT BECAME DEFORMED, AND IT WAS NOT POSSIBLE TO CROSS THROUGH THE STENT TO FULLY DEPLOY THE STENT. IT WAS ALSO REPORTED THAT THE LAD WAS DISSECTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21993453 ↗
• InjuryJan 7, 2025Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING A ONYX FRONTIER CORONARY DRUG ELUTING STENT TO ADDRESS AN 85% LESION STENOSIS IN A MILDLY TORTUOUS AND CALCIFIED LESION IN THE MID-RIGHT CORONARY ARTERY (RCA), STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING AND ADVANCEMENT. AN ATTEMPT TO CROSS THE ONYX FRONTIER STENT THROUGH A NON-MEDTRONIC STENT FAILED AND THE STENT WAS REMOVED. UPON INSPECTION THE STENT HAD STRUTS THAT WERE PULLED UP AND A DISSECTION WAS OBSERVED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED USING A NON-MEDTRONIC 2.0 X 12MM BALLOON. THE STENT DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS  ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. A 6F LAUNCHER GUIDE CATHETER AND A NON-MEDTRONIC GUIDEWIRE WERE USED WHEN ATTEMPTING TO DELIVER THE 2.5 X15 ONYX FRONTIER STENT DISTAL TO THE EXISTING STENT AND WHEN THE STENT FAILED TO CROSS THE LESION THE EXISTING GUIDE CATHETER WAS REMOVED. A NEW 6F LAUNCHER GUIDE CATHETER WAS INTRODUCED, ALONG WITH A TELESCOPE GUIDE EXTENSION CATHETER. AN ATTEMPT TO PASS ANOTHER 2.0 X 15MM ONYX FRONTIER STENT WAS MADE BUT WAS UNABLE TO CRO

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 21090084 ↗
• InjuryDec 9, 2024Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE LESION BEING TREATED WAS SEVERELY CALCIFICATION, MODERATELY TORTUOUS WITH 80-90% STENOSIS IN THE DISTAL OBTUSE MARGINAL (OM). THE LEFT ANTERIOR DESCENDING ARTERY (LAD) HAD SEVERE CALCIFICATION, DIAGONAL 1 HAD MID 80-90% STENOSIS, OTHERWISE MILD DISEASE THROUGHOUT. THERE WAS SEVERE CALCIFICATION IN THE LEFT MAIN (LM) WITH A PREVIOUS STENT THAT HAD IN-STENT RESTENOSIS (ISR) IN THE DISTAL SEGMENT. THERE WAS ALSO SEVERE CALCIFICATION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH 90% OSTIAL LCX ISR, MID LCX 60% STENOSIS, OM2 WITH 80-90% STENOSIS, OTHERWISE MILD DISEASE THROUGHOUT. THE STENT WAS ATTEMPTED TO BE DELIVERED TO THE DISTAL REGION BUT COULD NOT BE DELIVERED. UPON REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE STENT HAD BEEN STRIPPED OFF AND WAS INSIDE THE GUIDE. A GOOSENECK SNARE WAS USED TO SUCCESSFULLY REMOVE THE DISLODGED STENT FROM THE LM INTACT. IT WAS NO TED THAT THE PREVIOUSLY PLACED OSTIAL LM STENT HAD STRUTS HANGING OUT. A 4.5X8MM NON-MEDTRONIC BALLOON AND A 4.5X8 NON-MEDTRONIC NC BALLOON WERE

  Patient problems: Insufficient Information

  MAUDE report 20877259 ↗
• DeathNov 4, 2024Adverse 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 MODERATELY CALCIFIED, MILDLY TORTUOUS LESION WITH 70 TO 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. 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 THE STENT WOULD NOT CROSS INTO THE AREA NEEDED FOR DEPLOYMENT. RESISTANCE WAS NOT NOTED DURING THE WITHDRAWAL OF THE DEVICE. THE STENT WAS REMOVED AND UPON INSPECTION IT WAS NOTICED THAT THE STENT WAS NOT FULLY SEATED OVER THE BALLOON EVENLY BETWEEN THE MARKERS, AS USUAL. THE STENT APPEARED TO BE OFF BY A MILLIMETER OR TWO. A NEW SAME SIZE ONYX FRONTIER STENT WAS ABLE TO CROSS AND BE DEPLOYED. THE PATIENT WAS TRANSFERRED TO THE ICU AND EXPIRED TWO DAYS LATER.

  Patient problems: Insufficient Information

  MAUDE report 20597418 ↗
• DeathOct 16, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. 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 THE STENT WOULD NOT CROSS INTO THE AREA NEEDED FOR DEPLOYMENT. THE STENT WAS REMOVED AND UPON INSPECTION IT WAS NOTICED THAT THE STENT WAS NOT FULLY SEATED OVER THE BALLOON EVENLY BETWEEN THE MARKERS, AS USUAL. THE STENT APPEARED TO BE OFF BY A MILLIMETER OR TWO. A NEW SAME SIZE STENT WAS ABLE TO CROSS AND BE DEPLOYED. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20460035 ↗
• InjuryMay 28, 2024Device 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 LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE STENT PASSED THROUGH THE GUIDE CATHETER AND THE NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) INTO THE VESSEL. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO REPOSITION THE STENT WHEN IT WAS NOTED THAT THE STENT WAS OFF THE DELIVERY SYSTEM IN THE VESSEL. THE DELIVERY SYSTEM WAS REMOVED, AND ANOTHER BALLOON WAS INFLATED PAST THE UNDEPLOYED STENT. THE STENT WAS THE PULLED BACK INTO THE NON-MEDTRONIC GEC AND REMOVED FROM THE BODY. THE PATIENT WAS UNHARMED. NO FURTHER INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19404749 ↗
• InjuryMay 8, 2024Entrapment of Device; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Entrapment of Device; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS REMOVED BY USING 2.0MM BALLOON TO TRAP AND WITHDRAW IT. WIRE MOVEMENT ISSUE WAS ALSO REPORTED. IT WAS STATED THAT AFTER THE STENT DISLODGED, THE GUIDE WIRE HAD TO BE REMOVED AND A NEW GUIDEWIRE WAS INSERTED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273754 ↗
• InjuryApr 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY CALCIFIED LESION. 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 DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE DISLODGED STENT WAS NOT REMOVED, AND WAS CRUSHED AGAINST THE WALL OF THE ARTERY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY REPORTED.

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

  MAUDE report 19199677 ↗
• MalfunctionFeb 26, 2024Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A 2.0 X 20MM NON-MEDTRONIC 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 THE STENT WAS ATTEMPTED TO BE PLACED, BUT WHEN RESISTANCE WAS MET, THE STENT WAS REMOVED. AFTER REMOVAL A STENT STRUT WAS NOTED TO BE RAISED UPON INSPECTION, SO A NEW SAME SIZE ONYX FRONTIER STENT WAS OPENED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18776381 ↗
• InjurySep 1, 2023Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, MILDLY TORTUOUS LESION WITH 75% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. 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 DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE LESION WAS EXTREMELY CALCIFIED. THE PATIENT WAS ANXIOUS AND UNCOMFORTABLE FROM THE START OF THE CASE. MULTIPLE BALLOONS WERE USED, STARTING WITH A 2.5X15MM NON-MEDTRONIC BALLOON DOWN THE LAD OVER A NON-MEDTRONIC WIRE. ANOTHER NON-MEDTRONIC WIRE WAS PLACED IN THE DIAGONAL BRANCH. DIFFERENT SIZES OF BOTH COMPLIANT AND NON-COMPLIANT EUPHORA AND NON-MEDTRONIC BALLOONS WERE USED. SOME OF THE BALLOONS COULD NOT PASS THROUGH THE CALCIUM AT THE LESION OR EXPAND FULLY DUE TO THE CALCIUM. A TELESCOPE GUIDE EXTENSION CATHETER (GEC) WAS USED FOR SUPPORT TO PASS THE BALLOONS TO THE LESION. THE SMALL SIZE BALLOONS WERE USED FIRST, WORKING UP TO THE BIGGE

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

  MAUDE report 17669750 ↗
• InjuryJan 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE THREE ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY CALCIFIED LESION IN THE MID/PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SECOND DEVICE (ONYXNG25015UX). EXCESSIVE FORCE WAS USED DURING DELIVERY OF ALL DEVICES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION FOR THE FIRST TWO DEVICE (ONYXNG25008UX <(>&<)> ONYXNG25015UX). THE DISLODGED STENTS WERE NOT REMOVED. IT WAS POSSIBLE TO GET A BALLOON CATHETER THROUGH BOTH STENTS AND THE STENTS WERE DEPLOYED. SEVERAL BALLOONS WERE USED. FOR THE THIRD DEVICE (ONYXNG22526UX), IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16085239 ↗
• InjurySep 2, 2022Migration or Expulsion of Device; Device Damaged by Another Device; Material Deformation; Migration or Expulsion of Device; Device Damaged by Another Device; Material Deformation

  IT WAS ATTEMPTED TO USE ONE ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE AND THERE WAS NO EXCESSIVE FORCE USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO POST DEPLOYMENT. IT WAS STATED THERE WAS DIFFICULTY ENCOUNTERED WHEN DELIVERING THE IVUS CATHETER AND IT IS BELIEVED THAT IT MAY HAVE GOTTEN STUCK ON THE STRUTS OF THE STENT. THE STENT THEN MISSED THE LESION AND ANOTHER STENT HAD TO BE DEPLOYED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15347097 ↗