Onyx Frontier™ ONYXNG30038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00763000511531), received between Nov 11, 2022 and Jul 6, 2026 — classified as 2 deaths, 10 injuries, 11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2026Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE NC EUPHORA RX CORONARY BALLOON, DEFLATION DIFFICULTIES WERE ENCOUNTERED. THREE WEEKS PRIOR TO THE PROCEDURE THE PATIENT DEVELOPED NEW ON-SET PALPITATIONS/ANGINA AND WAS PRESCRIBED MEDICATION. THE PALPITATIONS PERSISTED AND APPROXIMATELY 6 DAYS PRIOR TO THE PROCEDURE THE PATIENT SUFFERED A SEVERE EPISODE WITH A HEART RATE OF 138 BPM AND BLOOD PRESSURE OF 118/80 MMHG, THIS EPISODE WAS TREATED WITH MEDICATION AND SYMPTOMS WERE REDUCED. THREE DAYS PRIOR TO THE PROCEDURE, THE PATIENT UNDERWENT A CARDIA CT DUE TO CHEST PAIN AND PALPITATIONS. THE CARDIAC CT WAS ABNORMAL AND REVEALED SEVERE CORONARY ARTERY DISEASE (CAD). A LEFT HEART CATHETERIZATION PROCEDURE WAS PLANNED AND DURING THE ELECTIVE OUTPATIENT PROCEDURE, THE PATIENT WAS NOTED TO HAVE HEAVY AND SCATTERED CALCIFICATION, EXHIBITING 80% STENOSIS IN THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH AN IFR MEASUREMENT OF 0.59, CONSISTENT WITH SIGNIFICANT AND OBSTRUCTIVE CORONARY ARTERY DISEASE. THE LEFT CORONARY ARTERY WAS ENGAGED USING A 6F LAUNCHER GUIDE CATHETER. THE LESION WAS PREDILATED WITH A NON-MEDTRONIC NC 3.0 MM BALLOON AND IVUS WAS PERFORMED. A DECISION WA

  Patient problems: Cardiac Arrest; Heart Block; Obstruction/Occlusion; Tachycardia; Ventricular Fibrillation

  MAUDE report 25716137 ↗
• MalfunctionMay 15, 2026Inflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, INFLATION DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON WOULD NOT INFLATE. THE BALLOON WOULD NOT HOLD PRESSURE TO DEPLOY THE STENT. THE LESION BEING TREATED WAS A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE 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. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25183587 ↗
• MalfunctionNov 6, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THREE ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE FOUND TO BE DAMAGED. ONE OF THE DEVICES DEPLOYED ON THE BACK TABLE. STENT DEFORMATION IN VIVO DURING POSITIONING/ADVANCEMENT OCCURRED ON THE OTHER TWO DEVICES AND THEY STARTED TO DEPLOY BEFORE PLACEMENT IN THE CORONARY ARTERY. INFLATION DEVICES WERE CONNECTED TO THE TWO DEVICES WHICH WERE DAMAGED WHILE ADVANCING THROUGH THE CALCIFIED LESION. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICES TO THE LESION. EXCESSIVE FORCE WAS NOT USED. THE STENTS WERE NOT IMPLANTED AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THE DEVICES WERE INSPECTED WITH ISSUES NOTED. NEGATIVE PREP/PURGING WAS PERFORMED ON THE DEVICE WHICH DEPLOYED ON THE BACK TABLE WITH ISSUES NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485860 ↗
• MalfunctionNov 6, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THREE ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE FOUND TO BE DAMAGED. ONE OF THE DEVICES DEPLOYED ON THE BACK TABLE. STENT DEFORMATION IN VIVO DURING POSITIONING/ADVANCEMENT OCCURRED ON THE OTHER TWO DEVICES AND THEY STARTED TO DEPLOY BEFORE PLACEMENT IN THE CORONARY ARTERY. INFLATION DEVICES WERE CONNECTED TO THE TWO DEVICES WHICH WERE DAMAGED WHILE ADVANCING THROUGH THE CALCIFIED LESION. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICES TO THE LESION. EXCESSIVE FORCE WAS NOT USED. THE STENTS WERE NOT IMPLANTED AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT DEVICE. THE DEVICES WERE INSPECTED WITH ISSUES NOTED. NEGATIVE PREP/PURGING WAS PERFORMED ON THE DEVICE WHICH DEPLOYED ON THE BACK TABLE WITH ISSUES NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23485763 ↗
• InjuryMay 21, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER DRUG ELUTING STENT, THE STENT DISLODGED DURING REMOVAL FOLLOWING A FAILED DELIVERY ATTEMPT AND FELL OFF AT THE OSTIUM. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA) AND WAS CHARACTERIZED BY SEVERE TORTUOSITY AND CALCIFICATION. THE DISLODGED STENT WAS NOT REMOVED BUT WAS INSTEAD CRUSHED INTO THE VESSEL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22067203 ↗
• InjuryMar 27, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; 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 DISLODGED STENT WAS SUCCESSFULLY REMOVED USING A SNARE. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21706049 ↗
• InjuryNov 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT UNINTENTIONALLY DISLODGED FROM THE STENT DELIVERY SYSTEM (SDS) BALLOON, IN AN EXTREMELY TORTUOUS VESSEL, DURING DELIVERY TO THE LESION. THE LESION WAS SEVERELY TORTUOUS, AND SEVERELY CALCIFIED AND LOCATED IN THE MID-DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT STAYED ON WIRE, AND ONE 2X12MM SPRINTER BALLOON AND ONE 3X15MM EUPHORA BALLOON WERE USED TO DILATE/EXPAND AND DEPLOY THE STENT IN THE VESSEL. THE PATIENT RECEIVED ALMOST 10GY IN DOSE. PREVIOUS TO THIS EVENT A NO CROSS STENT WAS DAMAGED ON INSPECTING UPON REMOVAL FROM THE BODY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 20809078 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO ONYX FRONTIER CORONARY DRUG-ELUTING STENTS WERE IMPLANTED TO TREAT A LESION WITH >90% STENOSIS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE RIGHT CORONARY (RCA) ARTERY. THE DEVICES WERE INSPECTED, WITH NO ISSUES NOTED. IT WAS REPORTED THAT AFTER 24 HOURS POST-STENT IMPLANTATION, ACUTE STENT THROMBOSIS OCCURRED. IT WAS DETAILED THAT THE PATIENT DEVELOPED CHEST DISCOMFORT AND CARDIAC ARREST AND WAS ULTIMATELY RESUSCITATED WITH THE PLACEMENT OF A NON-MEDTRONIC HEART PUMPS DEVICE. REPEAT ANGIOGRAPHY REVEALED STENT THROMBOSIS IN THE LAD THAT WAS TREATED SUCCESSFULLY WITH BALLOON ANGIOPLASTY AND MORE AGGRESSIVE POST-DILATATION. THE RIGHT CORONARY STENT ALSO HAD SMALL AMOUNTS OF THROMBUS, WHICH WERE TREATED WITH ASPIRATION THROMBECTOMY AND POST-DILATATION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Cardiac Arrest; Chest Pain; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 19533175 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO ONYX FRONTIER CORONARY DRUG-ELUTING STENTS WERE IMPLANTED TO TREAT A LESION WITH >90% STENOSIS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE RIGHT CORONARY (RCA) ARTERY. THE DEVICES WERE INSPECTED, WITH NO ISSUES NOTED. IT WAS REPORTED THAT AFTER 24 HOURS POST-STENT IMPLANTATION, ACUTE STENT THROMBOSIS OCCURRED. IT WAS DETAILED THAT THE PATIENT DEVELOPED CHEST DISCOMFORT AND CARDIAC ARREST AND WAS ULTIMATELY RESUSCITATED WITH THE PLACEMENT OF A NON-MEDTRONIC HEART PUMPS DEVICE. REPEAT ANGIOGRAPHY REVEALED STENT THROMBOSIS IN THE LAD THAT WAS TREATED SUCCESSFULLY WITH BALLOON ANGIOPLASTY AND MORE AGGRESSIVE POST-DILATATION. THE RIGHT CORONARY STENT ALSO HAD SMALL AMOUNTS OF THROMBUS, WHICH WERE TREATED WITH ASPIRATION THROMBECTOMY AND POST-DILATATION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Cardiac Arrest; Chest Pain; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 19533172 ↗
• DeathMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). ONE LAUNCHER GUIDE CATHETER, ONE EUPHORA BALLOON CATHETER, FIVE NC EUPHORA BALLOON CATHETERS, AND ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) WERE ALSO USED DURING THE PROCEDURE. NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE. ON THE SAME DAY POST PROCEDURE THE PATIENT SUFFERED FROM A SPONTANEOUS MYOCARDIAL INFARCTION (MI) AND CARDIAC ARREST / SUDDEN CARDIAC DEATH. THE PATIENT WAS DOING WELL AFTER THE PROCEDURE, HAD EATEN DINNER AND EVERYTHING WAS NORMAL WHEN SUDDENLY THE PATIENT COLLAPSED ON THE GROUND. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF CHEST PAIN, DIAPHORESIS, NAUSEA, OR VOMITING. ADVANCED LIFE SAVING MEASURES WERE UTILIZED. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED AND A FAMILY MEMBER TRIED TO DO SOME MOUTH-TO-MOUTH UNTIL THE AMBULANCE ARRIVED. WHEN THE AMBULANCE ARRIVED, THEY DETECTED ELECTROMECHANICAL DISSOCIATION (EMD) AND STARTED CARDIOPULMONARY RESUSCITATION (CPR) FOR 30 MINUTES BEF ORE THE PATIENT ARRIVED TO THE EMERGENCY ROOM (ER). ADDITIONAL CPR WAS PERFORMED, HOWEVER, THIS WAS UNSUCCESSFUL IN OBTAINING BLOOD PRESSURE. T

  Patient problems: Cardiac Arrest; Myocardial Infarction

  MAUDE report 18947606 ↗
• InjuryFeb 20, 2024Entrapment of Device; Difficult to Insert; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Entrapment of Device; Difficult to Insert; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE AN ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). 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 DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED. THE DEVICE WAS NOT ABLE TO CROSS A DISTAL LESION AND UPON RETRACTION THE STENT STOPPED IN THE MID RCA AND COULD NOT BE RETRACTED ANY FURTHER. WHEN THE STENT WAS STOPPED AND STUCK IN THE MID RCA, WHILE STILL ON THE BALLOON, IT WAS NOTICED THE STENT HAD LONGITUDINAL STENT DEFORMATION (LSD). A SECOND CORONARY WIRE (COUGAR XT) WAS PLACED DOWN THE RCA AND THE STENT WAS RETRACTED TO THE PROXIMAL RCA. HOWEVER, THE STENT WOULD NOT ENTER INTO THE GUIDE CATHETER. AT THAT POINT IN THE PROXIMAL RCA, THE STENT DISLODGED OFF THE BALLOON. A 1.5 BALLOON WAS PLACED INSIDE THE DISLODGED STENT AND INFLATED. SEQUENTIAL LARGER BALLOONS WERE TH

  Patient problems: Insufficient Information

  MAUDE report 18736956 ↗
• MalfunctionFeb 7, 2024Material Deformation; Material Deformation

  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 MID 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 NOTED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS DETAILED THAT THE STENT STRUT WAS FLARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME SIZE ONYX FRONTIER STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18662146 ↗
• MalfunctionDec 18, 2023Difficult to Insert; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Difficult to Insert; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) AND ONE TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A LESION. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE WAS PREPPED PER IFU WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE TELESCOPE GEC. EXCESSIVE FORCE WAS NOT USED DURING INSERTION/DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED WHEN THE STENT WAS BEING ADVANCED THROUGH THE TELESCOPE. IT WAS DETAILED THAT THE STENT GOT STUCK ON THE TELESCOPE 6F CATHETER AND WAS DEFORMED. IT WAS NOTED THAT STENT DISLODGEMENT ALSO OCCURRED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18350211 ↗
• MalfunctionDec 8, 2023Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. 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 DETAILED THAT THE STENT WAS REMOVED BECAUSE IT FAILED TO CROSS THE LESION. ONCE REMOVED THE BENT STENT STRUT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME SIZE ONYX FRONTIER DEVICE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293461 ↗
• MalfunctionJun 13, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON THE DEVICE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH 2.5X12MM EUPHORA BALLOON AT 12ATM FOR 8 SECONDS AND AGAIN AT 17ATM FOR 8 SECONDS. THE ONYX FRONTIER DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. THE STENT WAS PREPPED APPROPRIATELY PRIOR TO DEPLOYMENT. THE ONYX FRONTIER STENT WAS INFLATED AT 18ATM FOR 26 SECONDS. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED. THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS ALSO DETAILED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AS THE BALLOON HAD TO BE REMOVED WHILE STILL INFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17117754 ↗
• MalfunctionMay 31, 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. IT WAS REPORTED THAT DEVICE FAILED TO CROSS THE LESION AND WHEN REMOVING THE UNDEPLOYED STENT FROM THE PATIENT, THE STENT BECAME ENTRAPPED IN THE NON-MEDTRONIC GUIDE CATHETER. THE STENT WAS REMOVED WITH THE GUIDE CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17028834 ↗
• DeathMay 15, 2023Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT DISLODGED FROM THE BALLOON WHEN ADVANCING THE STENT INTO THE LEFT MAIN (LM) ARTERY TO TREAT THE CX LESION. IT WAS DETAILED THAT ALL ATTEMPTS TO SNARE THE DISLODGED STENT FAILED. THE PATIENT WAS IMMEDIATELY MOVED TO SURGERY IN AN ATTEMPT TO RECOVER THE DISLODGED STENT. THE PATIENT DIED DURING THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 16934575 ↗
• MalfunctionMay 15, 2023Fracture; Device Dislodged or Dislocated; Fracture; 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 THE DEVICE FRACTURED. ON THE STENT BOX " STENT FRACTURED" WAS WRITTEN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16929253 ↗
• InjuryApr 13, 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 LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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. THE STENT WAS STRIPPED OFF OF THE STENT DELIVERY SYSTEM (SDS) AND A SNARE WAS USED IN AN ATTEMPT TO RETRIEVE IT. HOWEVER, THIS WAS UNSUCCESSFUL. THE DISLODGED STENT WAS CRUSHED IN THE RCA AND STENTED OVER. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16731846 ↗
• MalfunctionApr 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX (CX) 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS DETAILED THAT HAVING CROSSED THE LESION THE BALLOON WAS INFLATED TO DEPLOY THE STENT, HOWEVER IT WAS NOTICED THAT THE STENT HAD PREVIOUSLY COME OFF ON THE SHAFT. WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT WAS STUCK INSIDE THE DELIVERY SYSTEM. THE STENT WAS REPLACED WITH ANOTHER ONYX FRONTIER STENT WITHOUT INCIDENCE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717848 ↗
• MalfunctionJan 26, 2023Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO 6F TELESCOPE GUIDE EXTENSION CATHETERS (GEC) AND ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, MILDLY TORTUOUS LESION WITH 100% CHRONIC TOTAL OCCLUSION (CTO), LOCATED IN THE MID SAPHENOUS VEIN GRAFT (SVG). THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE TELESCOPE DEVICES. THE TELESCOPE DEVICES WERE REMOVED FROM THE PACKAGING AND PREPPED PER IFU WITH NO ISSUES NOTED. THE TELESCOPE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE TELESCOPE DEVICES. EXCESSIVE FORCE WAS NOT USED. THE TELESCOPE DEVICES WERE NOT EXCESSIVELY TORQUED. IT WAS REPORTED THAT RESISTANCE WAS EXPERIENCED DURING DELIVERY TO THE TARGET LESION, WITH OTHER DEVICES INSERTED THROUGH LUMEN OF TELESCOPE DEVICES. DURING USE WITH THE FIRST TELESCOPE DEVICE THE ONYX FRONTIER STENT 'HIT' SOMETHING AND WOULDN'T ENTER THE LUMEN OF THE TELESCOPE. THERE WAS RESISTANCE WHEN TRYING TO ENTER THE TELESCOPE LUMEN. THE ONYX FRONTIER STENT WAS STRIPPED AND THERE WAS DAMAGE TO THE STENT DEVICE. THE STENT WAS STILL ON THE BALLOON BUT WAS NOTED TO BE UNRAVELED. THE DAMAGE OCCURRED INSIDE THE BODY AS THE STENT WAS TRYING TO ENTER THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16245276 ↗
• InjuryJan 17, 2023Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation; Inflation Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED DURING BALLOON INFLATION, AND STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS DETAILED THAT THE BALLOON WOULD NOT INFLATE TO DEPLOY THE STENT AT THE LESION. THE STENT STARTED INFLATING BUT BALLOON EXPANSION WAS NEVER SEEN. THE INFLATION DEVICES WERE CHANGED BUT THE STENT WAS STILL WAS NOT VISIBLY INFLATING. UPON PULLING THE STENT DELIVERY SYSTEM OUT IT WAS NOTED THAT THE STENT HAD SLIGHTLY DEPLOYED AND GOT CAUGHT ON THE TIP OF THE GUIDE. EVERYTHING WAS ATTEMPTED TO BE REMOVED AS ONE SYSTEM, BUT THE STENT WOULD NOT COME OUT ONCE IT GOT INTO THE RADIAL ARTERY. THE STENT DISLODGED IN THE RADIAL ARTERY UPON TRYING TO REMOVE THE STENT FROM THE BODY. THE STENT HAD TO BE SURGICALLY REMOVED VIA A CUT DOWN. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16184284 ↗
• InjuryNov 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 100% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. DURING REMOVAL THE STENT WAS STILL MOSTLY ON THE DELIVERY SYSTEM, HOWEVER, THE STENT WOULD NOT COME BACK INTO THE GUIDE CATHETER. THE STENT STRUTS ON THE PROXIMAL END OF THE STENT WERE GETTING PUSHED IN. THE DISLODGED STENT WAS NOT REMOVED, IT WAS INSTEAD DEPLOYED PROXIMAL TO THE LESION SITE. A 3.0 X 18MM ONYX STENT WAS IMPLANTED DISTAL TO THE DEPLOYED DISLODGED STENT, AND THE PROCEDURE WAS FINISHED WITH EXCELLENT RESULT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15778983 ↗