Onyx Frontier™ ONYXNG25018UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00763000511302), received between Aug 3, 2022 and Jul 21, 2026 — classified as 2 deaths, 12 injuries, 10 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE PREVAIL DRUG COATED BALLOON (DCB) WAS USED TO TREAT A LESION WITH 70% STENOSIS AND IN STENT RESTENOSIS (ISR) IN AN ONYX FRONTIER DRUG ELUTING STENT IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THERE WERE MULTIPLE MEDTRONIC STENTS PLACED IN THE RCA ORIGINALLY APPROXIMATELY 12 MONTHS PREVIOUSLY FROM THE PROXIMAL RCA TO DISTAL RCA. THE AREA THAT WAS TREATED FOR ISR DURING THE INDEX PROCEDURE WAS THE DISTAL RCA. THE STENT IN THE DISTAL RCA WAS A 2.5X18MM ONYX FRONTIER STENT. APPROXIMATELY 6 MONTHS POST THE INDEX PROCEDURE THE PATIENT SUFFERED FROM CHEST PAIN/UNSTABLE ANGINA. WHEN THE PATIENT WAS SEEN IN CARDIOLOGY, THE PATIENT COMPLAINED OF WORSENING DYSPNEA ON EXERTION AND SPORADIC CHEST PAIN 1 TO 2 TIMES A DAY. DUE TO THE PATIENTS HISTORY OF IN STENT RESTENOSIS, THE PATIENT WAS SCHEDULED FOR A CATH. HOWEVER, THE PATIENT PRESENTED TO THE ER PRIOR TO THIS APPOINTMENT WITH 2 DAYS OF LEFT SIDED CHEST PRESSURE ASSOCIATED WITH LIGHT HEADEDNESS AND SHORTNESS OF BREATH WITH MINIMAL EXERTION. THE PATIENT WAS HOSPITALIZED. AN EKG PERFORMED FOUND 1ST DEGREE AV BLOCK WITH NO ST ELEVATION. TROPONINS AT BASELINE WERE 8 AND AT 2 AND 6 HOURS THERE WAS NO CHANGE FROM BASE

  Patient problems: Angina; Chest Pain; Dizziness; Dyspnea; Heart Block; Restenosis

  MAUDE report 25890213 ↗
• InjuryMar 13, 2026Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (PROXIMAL AND DISTAL SEGMENTS) WITH MODERATE TORTUOSITY AND MILD CALCIFICATION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS ADVANCED THROUGH A PREVIOUSLY DEPLOYED STENT WITH NO RESISTANCE ENCOUNTERED OR EXCESSIVE FORCE USED DURING DELIVERY. THE STENT WAS BELIEVED TO HAVE BECOME CAUGHT ON THE STRUTS OF EITHER PREVIOUSLY IMPLANTED STENTS IN THE RIGHT CORONARY ARTERY OR ON THE STRUTS OF AN EVOLUT TRANSCATHETER AORTIC VALVE REPLACEMENT THAT HAD BEEN PLACED INSIDE A SURGICAL AORTIC VALVE REPLACEMENT. THE STENT WAS NOT REMOVED; INSTEAD, IT WAS CRUSHED USING A BALLOON (PLAIN OLD BALLOON ANGIOPLASTY). A NON MEDTRONIC 5.5 FR GUIDELINER WAS USED TO DELIVER THE STENT. THE PROCEDURE WAS CONSIDERED A SUCCESSFUL POBA. 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 24589946 ↗
• DeathMar 5, 2026Entrapment of Device; Difficult to Remove; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION EXHIBITED SEVERE CALCIFICATION WITH CALCIUM REPORTED IN THE VESSEL. THE DEVICE WAS INSPECTED PRIOR TO USE 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 AND THE DEVICE BECAME STUCK DURING DELIVERY. UPON REMOVAL OF THE STENT CATHETER, IT WAS OBSERVED THAT THE STENT WAS NO LONGER SECURED TO THE BALLOON, INDICATING STENT DISLODGMENT. AN UNSUCCESSFUL SNARE ATTEMPT WAS MADE TO RETRIEVE THE DISLODGED STENT, WHICH WAS NOT RECOVERABLE. THE PATIENT EXPIRED DURING THE PROCEDURE.

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

  MAUDE report 24517309 ↗
• InjuryJan 14, 2026Fracture; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE DEVICE DETACHED, CRACKED OR FRACTURED DURING REMOVAL OF THE DEVICE. THE DETACHED PORTION OF DEVICE REMAINS IN THE PATIENT. THE LESION BEING TREATED WAS IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. RESISTANCE WAS NOT 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: Device Embedded In Tissue or Plaque

  MAUDE report 24066614 ↗
• MalfunctionDec 22, 2025Difficult to Advance; Material Deformation; Positioning Problem; Difficult to Advance; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE STENT WAS REMOVED FROM THE HOOP AND ADVANCED THROUGH THE GUIDE TO THE PROXIMAL RCA, WHERE IT WAS UNABLE TO CROSS THE LESION. THE STENT WAS REMOVED FROM THE BODY AND FLUSHED AND RE ADVANCED WHEN IT WAS NOTICED THAT THE STENT SURFACE WAS UNEVEN. THE LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE DEVICE WAS INSPECTED PRIOR TO USE 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 AND 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 23861878 ↗
• MalfunctionSep 10, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Deformation Due to Compressive Stress; 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 DURING ADVANCEMENT THROUGH THE GUIDE CATHETER. THE TARGET LESION WAS LOCATED IN THE DISTAL CIRCUMFLEX (CX) ARTERY WHICH EXHIBITED MODERATE TORTUOSITY, MODERATE CALCIFICATION AND 80% STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DETACHED PORTION OF DEVICE DOES NOT REMAIN IN THE PATIENT. THE DEVICE WAS REMOVED FROM THE PATIENT WITH NO INCIDENT AS PART OF THE CATHETER SHAFT REMAINED OUTSIDE THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020542 ↗
• DeathAug 13, 2025Inflation Problem; Deformation Due to Compressive Stress; Material Deformation; Inflation Problem; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED DURING THE DEPLOYMENT OF ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT. UPON AT TEMPTED INFLATION, ONLY THE DISTAL EDGES OF THE BALLOON INFLATED IN THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) ARTERY, AND THE STENT FAILED TO EXPAND. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE, WITH NO ISSUES OBSERVED. THE LESION HAD BEEN PRE-DILATED BEFORE THE ATTEMPTED DEPLOYMENT, AND NO RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE TO THE LESION. THE SAME INFLATION DEVICE WAS USED FOR BOTH THE PRE-DILATION BALLOON AND THE STENT BALLOON. NOMINAL PRESSURE OF 12 ATM WAS APPLIED WHEN THE INFLATION DIFFICULTIES WERE IDENTIFIED. THE PATIENT EXPERIENCED CARDIAC ARREST, WAS INTUBATED, DEFIBRILLATED, AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). THE PHYSICIAN BELIEVES THE INFLATION DIFFICULTIES CAUSED OCCLUSION OF FLOW IN THE LAD. THE PATIENT SUBSEQUENTLY EXPIRED IN THE ICU.

  Patient problems: Cardiac Arrest; Coronary obstruction/occlusion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798134 ↗
• MalfunctionJan 22, 2025Burst Container or Vessel; Inflation Problem; Leak/Splash; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Split, Cut or Torn; Burst Container or Vessel; Inflation Problem; Leak/Splash; Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE BALLOON EXPERIENCED A BURST OR LEAK DURING INFLATION. THE DEVICE FAILED TO INFLATE ON THE FIRST ATTEMPT, PREVENTING THE DEPLOYMENT OF THE STENT IN THE LEFT CIRCUMFLEX ARTERY (LCX). IT WAS ASSUMED THAT THE BALLOON HAD A HOLE IN IT THAT PREVENTED THE INFLATION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THERE WAS NO EXCESSIVE FORCE USED DURING DELIVERY. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21206189 ↗
• InjuryOct 3, 2024Deflation Problem; Migration or Expulsion of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Deflation Problem; Migration or Expulsion of Device; Device Damaged by Another Device; 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 BALLOON DEFLATION DIFFICULTIES OCCURRED, AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. A GUIDEWIRE WAS USED TO HELP DISLODGE THE BALLOON FROM THE STENT, HOWEVER, IN THE PROCESS THE STENT MOVED AND HAD TO BE RETRIEVED. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 20358105 ↗
• InjurySep 30, 2024Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION 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. IT WAS REPORTED THAT THE STENT BALLOON RUPTURED DURING STENT DEPLOYMENT. NOMINAL INFLATION PRESSURE WAS APPLIED TO THE BALLOON PRIOR TO THE RUPTURE. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 20332032 ↗
• InjuryJul 4, 2024Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE OSTIUM OF THE DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE DIAGONAL LESION WAS PRE-DILATED USING A COMPLIANT BALLOON. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT WAS RETRIEVED SUCCESSFULLY USING A SNARE. THE CIRCUMFLEX ARTERY WAS FIRST STENTED AND AN ATTEMPT WAS THEN MADE TO DELIVER THE ONYX FRONTIER STENT TO THE DIAGONAL LESION. RESISTANCE WAS FELT SO THE ONYX FRONTIER STENT WAS PULLED OUT AND IT DISLODGED IN THE LEFT MAIN (LM). IT WAS STATED THAT THE ONYX FRONTIER STENT PROBABLY CAUGHT ON THE PREVIOUSLY DEPLOYED STENT LOCATED IN THE CIRCUMFLEX ARTERY. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19673614 ↗
• MalfunctionJul 4, 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 LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS. IT WAS REPORTED THAT AFTER ATTEMPTING TO CROSS THE LESION MULTIPLE TIMES THE STENT STRUT RAISED UP DUE TO CALCIUM. A LAUNCHER GUIDE CATHETER, TWO NON-MEDTRONIC GUIDEWIRES, MULTIPLE NC NON-MEDTRONIC BALLOONS AND A NON-MEDTRONIC GUIDE EXTENSION CATHETER WERE USED TO HELP DEPLOY THE STENT. IT WAS FOUND THAT THE STENT WAS DAMAGED AFTER THESE ATTEMPTS AND ANOTHER ONYX FRONTIER 2.5 X18 WAS DEPLOYED SUCCESSFULLY. A 3.0 X 15 ONYX FRONTIER WAS ALSO DEPLOYED IN THE PROXIMAL LAD. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19673285 ↗
• MalfunctionMay 3, 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 (DES) TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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. IT WAS STATED THAT THE STENT CAME OFF WITH THE STYLET HOWEVER, IT WAS NOT NOTICED THAT THE STENT WAS OFF UNTIL AFTER THE STENT CATHETER WAS INFLATED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243575 ↗
• InjuryFeb 20, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 95% STENOSIS IN THE MID AND PROXIMAL CIRCUMFLEX (CX) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON BOTH DEVICES WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY FOR BOTH STENTS. BOTH STENTS WERE REMOVED USING A 25MM GOOSENECK SNARE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18737061 ↗
• MalfunctionFeb 16, 2024Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  THE PATIENT WAS BROUGHT TO THE HOSPITAL DUE TO AN ABNORMAL STRESS TEST. AN ANGIOGRAM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY REVEALED 50% MID LAD STENOSIS. THE RIGHT CORONARY ARTERY (RCA) WAS SEVERELY CALCIFIED. AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED DIFFUSE TYPE C LESION WITH 90% STENOSIS, IN THE MID RCA. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH A 2.5X15MM BALLOON AT 14 ATM FOR 20 SECONDS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION, AND STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. A JR4 GUIDE CATHETER ENGAGED THE RCA VIA RIGHT RADIAL ACCESS. A NON-MEDTRONIC (MDT) WIRE WAS USED TO CROSS THE MID RCA. AFTER PRE-DILATION AN ATTEMPT WAS MADE TO CROSS THE LESION WITH THE STENT BUT WAS UNSUCCESSFUL. FURTHER PRE-DILATIONS WERE PERFORMED WITH THE 2.5MM BALLOON. A GUIDE EXTENSION AND A BUDDY WIRE WERE ADDED WITHOUT SUCCESS. THE GUIDE CATHETER WAS THEN CHANGED TO AN AL1 GUIDE CATHETER ALONG WITH ANOTHER NON-MDT WIRE, BUT THIS WAS UNSUCCESSFUL. AN ATTEMPT WAS MADE TO

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

  MAUDE report 18720286 ↗
• InjuryJan 26, 2024Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE TELESCOPE GUIDE EXTENSION CATHETER AND ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE VESSEL TORTUOSITY AND CALCIFICATION MADE IT DIFFICULT FOR PASSAGE OF EQUIPMENT. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE WAS PREPPED PER IFU WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON THE ONYX FRONTIER WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE ONYX FRONTIER DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THERE WAS DAMAGE TO THE TIP OF THE TELESCOPE DEVICE, AND STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE TIP OF THE TELESCOPE TIP WAS TORN. THE STENT SNAGGED ON THE TIP OF THE TELESCOPE CATHETER AND CAME OFF THE DELIVERY SYSTEM. AFTER REMOVING THE TELESCOPE DEVICE, THE STENT WAS ABLE TO BE RETRIEVED BY USING A SMALLER PLATFORM. ALL DEVICES WERE RETRIEVED EVENTUALLY WITH NO ADVERSE EFFECTS ON THE PATIENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18585804 ↗
• MalfunctionDec 20, 2023Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS DETAILED THAT WHEN THE STENT WAS LOADED ON A 0.014 GUIDEWIRE, IT WAS STICKY. THE STENT WAS REMOVED AND THE WIRE WAS WIPED DOWN WITH HEPARINIZED SALINE. WHEN IT WAS ATTEMPTED TO LOAD THE STENT BACK ON THE GUIDEWIRE FOR A SECOND TIME, IT WAS NOTED THAT THE TIP OF STENT WAS FLARED UP. IT WAS STATED THAT THIS MAY HAVE HAPPENED DURING THE REMOVAL AFTER THE INITIAL ATTEMPT TO LOAD THE STENT ONTO THE GUIDEWIRE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364446 ↗
• MalfunctionOct 26, 2023Device Damaged by Another Device; Device Damaged by Another Device

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS LESION IN THE LEFT MAIN (LM) CORONARY ARTERY. 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 DELIVERY TO/AT THE LESION. IT WAS LATER REPORTED THAT THE ONYX FRONTIER STENT WAS PASSING THROUGH TWO FRESHLY DEPLOYED ONYX FRONTIER STENTS IN THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) (ONYXNG25018UX ¿ PLI20) AND THE OSTIAL HIGH DIAGONAL (ONYXNG22512UX ¿ PLI30) WHEN THE STENT STRIPPED OFF. THE ONYX FRONTIER STENT IN THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) HAD BEEN DEPLOYED USING A MINICRASH TECHNIQUE. IT WAS REPORTED TH AT THE 2.25X18MM ONYX FRONTIER STENT (PLI10) GOT HUNG UP TRYING TO PASS THE DEPLOYED STENTS. IT IS UNCLEAR OF THE EXTENT OF THE ROLE OF THE PREVIOUSLY PLACED STENTS. IT WAS REPORTED THAT THE 2.25X18MM ONYX FRONTIER STENT (PLI10) WAS STRIPPED OFF THE BALLOON WHEN AN ATTEMPT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18009526 ↗
• InjurySep 26, 2023Device 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 DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED. IT WAS DETAILED THAT ONCE THE STENT WAS IN THE LESION IT WAS DETERMINED THAT A LONGER STENT WAS NEEDED. AS THE STENT WAS BEING REMOVED FROM THE VESSEL THE STENT CAME OFF THE STENT DELIVERY SYSTEM. WIRE POSITION WAS MAINTAINED AND A BALLOON WAS USED TO EXPAND THE STENT. THEN ANOTHER STENT WAS USED AND EXPANDED AS WELL. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 17816172 ↗
• MalfunctionAug 30, 2023Fracture; Fracture

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE DEVICE CRACKED OR FRACTURED DURING ADVANCEMENT THROUGH AN UNKNOWN GUIDE CATHETER. IT WAS DETAILED THAT THE SHAFT OF THE CATHETER FRACTURED DISTAL TO THE GUIDE CATHETER HUB. THE STENT DELIVERY SYSTEM WAS REMOVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17648468 ↗
• MalfunctionFeb 8, 2023Inflation Problem; Detachment of Device or Device Component; Inflation Problem; 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 IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES OCCURRED. THE DEVICE WAS PULLED NEGATIVE WHEN IT WAS REALIZED THAT SOMETHING DIDN'T FEEL RIGHT. THE STENT WAS REMOVED FROM THE GUIDE AND IT WAS NOTICED THAT THE SHAFT WAS BROKEN. THE PATIENT IS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16322483 ↗
• InjuryFeb 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS USED TO TREAT A VERY CALCIFIED LESION IN THE PROXIMAL MID 1ST MARGINAL AND LEFT CIRCUMFLEX. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. DURING THE PROCEDURE A 3.5 EBU LAUNCHER GUIDE CATHETER AND A NON MDT WIRE WERE USED. THE LESION WAS PRE-DILATED USING A 2.5X 20 MM COMPLIANT BALLOON AT 12 ATM. IT WAS ATTEMPTED TO USE A 2.5 X 48 NON MDT STENT BUT WOULD NOT GO THROUGH THE LESION. IT WAS TRIED AGAIN WITH BUDDY WIRE, BUT IT STILL WOULD NOT GO. THE BUDDY WIRE WAS REMOVED AND A NON MDT GUIDE EXTENSION CATHETER (GEC) WAS USED WITH THE STENT BUT IT WAS STILL UNSUCCESSFUL. THEREFORE, A 2.5 X18MM ONYX FRONTIER DRUG ELUTING STENT WAS USED WITH THE GEC BUT IT DID NOT PASS. THE GEC WAS REMOVED AND A SECOND BUDDY WIRE WAS USED BUT WHEN ATTEMPTED AGAIN, THE 2.5 X18MM ONYX FRONTIER STENT WOU LD NOT ADVANCE. THE ONYX FRONTIER STENT WAS REMOVED. A 3.0 X 20 NON COMPLIANT BALLOON WAS DILATED IN THE MID PORTION OF THE LESION. IT WAS ATTEM

  Patient problems: Insufficient Information

  MAUDE report 16311156 ↗
• InjuryFeb 2, 2023Inflation Problem; Leak/Splash; Device Dislodged or Dislocated; Inflation Problem; Leak/Splash; Device Dislodged or Dislocated

  AN ATTEMPTED WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THEIR RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THERE WAS INFLATION DIFFICULTIES DURING STENT DEPLOYMENT, AND STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WOULD NOT DEPLOY WITH THE DELIVERY BALLOON. IT WAS DETERMINED THAT THERE WAS INFLATION DIFFICULTIES WHEN 4 ATM OF PRESSURE WAS APPLIED. WHEN ATTEMPTING TO REMOVE THE STENT, THE STENT DISLODGED IN THE PROXIMAL PART OF THE ARTERY. THE DISLODGED STENT WAS NOT REMOVED. THE STENT REMAINED ON THE WIRE. A 2.0 MM BALLOON WAS THREADED THROUGH THE STENT AND THE STENT WAS EXPANDED AND DEPLOYED IN THE PROXIMAL PART OF THE ARTERY. A NEW 2.5 X 18 MM ONYX FRONTIER STENT WAS THEN DEPLOYED AT THE ORIGINAL LESION SITE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16282173 ↗
• 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; Vascular Dissection

  MAUDE report 15154698 ↗