Onyx Frontier™ ONYXNG30022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000511494), received between Sep 6, 2022 and May 6, 2026 — classified as 2 deaths, 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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.

• MalfunctionMay 6, 2026Burst Container or Vessel; Leak/Splash; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE 3.0 X 22MM ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) WHEN THE BALLOON RUPTURED DURING STENT DEPLOYMENT ON THE FIRST INFLATION AT NOMINAL PRESSURE. THE STENT STAYED ON THE BALLOON FOR A MOMENT AND EVENTUALLY LODGED DURING ATTEMPTED REMOVAL. THE STENT WAS SUCCESSFULLY DEPLOYED IN THE DISTAL RIGHT CORONARY ARTERY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. A NEW 3.0 X 22MM ONYX FRONTIER DES WAS ATTEMPTED TO BE USED WITH A NEW INDEFLATOR WHEN THE BALLOON ALSO RUPTURED DURING ATTEMPTED STENT DEPLOYMENT DURING THE FIRST INFLATION AT NOMINAL PRESSURE. THIS STENT STAYED MOSTLY IN PLACE AND WAS INFLATED WELL TO APPOSE THE STENT TO THE WALL. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES.NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093687 ↗
• MalfunctionMay 6, 2026Burst Container or Vessel; Leak/Splash; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE 3.0 X 22MM ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) WHEN THE BALLOON RUPTURED DURING STENT DEPLOYMENT ON THE FIRST INFLATION AT NOMINAL PRESSURE. THE STENT STAYED ON THE BALLOON FOR A MOMENT AND EVENTUALLY LODGED DURING ATTEMPTED REMOVAL. THE STENT WAS SUCCESSFULLY DEPLOYED IN THE DISTAL RIGHT CORONARY ARTERY. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. A NEW 3.0 X 22MM ONYX FRONTIER DES WAS ATTEMPTED TO BE USED WITH A NEW INDEFLATOR WHEN THE BALLOON ALSO RUPTURED DURING ATTEMPTED STENT DEPLOYMENT DURING THE FIRST INFLATION AT NOMINAL PRESSURE. THIS STENT STAYED MOSTLY IN PLACE AND WAS INFLATED WELL TO APPOSE THE STENT TO THE WALL. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES.NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093664 ↗
• MalfunctionJan 5, 2026Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, THE STENT CAME OFF THE BALLOON WHILE IN A NON MEDTRONIC GUIDE EXTENSION CATHETER. THERE WAS A HEAVILY CALCIFIED AREA IN THE LESION THAT WAS ADDRESSED WITH ROTABLATION AND SHOCKWAVE PRIOR TO STENT INSERTION. THE STENT WAS IN THE PATIENTS BODY AND THERE WERE SEVERAL ATTEMPTS TO CROSS THE LESION FROM THE LEFT MAIN INTO THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THERE WERE NO PATIENT ADVERSE EFFECTS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955788 ↗
• DeathOct 22, 2025Inadequacy of Device Shape and/or Size; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Inadequacy of Device Shape and/or Size; Device Damaged by Another 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 A FAILED DELIVERY AS IT WAS ASSESSED A DIFFERENT STENT SIZE MAY BE REQUIRED. THE STENT WAS NOT ATTEMPTED TO BE RETRIEVED; IT WAS ATTEMPTED TO BE DILATED. ONLY THE PROXIMAL PORTION OF THE STENT WAS ABLE TO BE DILATED. ATTEMPTS WERE MADE TO PASS A BALLOON IN THE DISTAL PORTION OF THE STENT TO DILATE IT AS WELL, BUT THOSE ATTEMPTS WERE UNSUCCESSFUL. NEW BALLOONS WERE USED IN THIS ATTEMPT. THE TARGET LESION WAS LOCATED IN THE MID/PROXIMAL RIGHT CORONARY ARTERY (RCA) WHICH EXHIBITED SEVERE CALCIFICATION AND MILDLY TORTUOSITY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITH A 2.0X15MM EUPHORA BALLOON FOLLOWED BY 2.5X12MM NC EUPHORA BALLOON. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED ONYX FRONTIER STENT THAT WAS DEPLOYED JUST BEFORE THE 3X22MM STENT THAT WAS DISLODGED FROM THE DELIVERY SYSTEM. A 6FR LAUNCHER GUIDE CATHETER, A NON-MEDTRONIC GUIDE WIRE, AND A 5.5FR NON-ME DTRONIC GUID

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

  MAUDE report 23356057 ↗
• InjuryJan 23, 2025Burst Container or Vessel; Inflation Problem; Leak/Splash; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Burst Container or Vessel; Inflation Problem; Leak/Splash; 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, A BALLOON BURST/LEAK OCCURRED DURING STENT DEPLOYMENT AT AN INFLATION PRESSURE OF 8 ATM. THE ISSUE OCCURRED ON THE FIRST INFLATION. THE LESION BEING TREATED WAS MILDLY TORTUOUS, MODERATELY CALCIFIED WITH 85% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREPARATION WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. 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 21216654 ↗
• MalfunctionJan 21, 2025Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT WAS RETURNED. INFORMATION ON THE RETURNED PACKAGING INDICATED THAT THE DEVICE WAS BROKEN WHILE IN THE BODY, BUT ALSO STATES THAT THE DEVICE MAY HAVE BEEN BROKEN BEFORE IT WENT IN THE BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21196163 ↗
• InjuryAug 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE 2.75 X 26 MM ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED LESION IN THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0 X 22MM ONYX FRONTIER STENT AND A 3.0 X 18MM ONYX FRONTIER STENT WERE ALSO ATTEMPTED TO BE USED DURING THE PROCEDURE TO TREAT A LESION. THE DEVICES WERE INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE 3.0 X 22MM ONYX FRONTIER STENT AND A 3.0 X 18MM ONYX FRONTIER STENT WERE PREPPED PER IFU WITH NO ISSUES NOTED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE 2.75 X 26 MM ONYX FRONTIER STENT AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE 2.75 X 26 MM ONYX FRONTIER STENT CAME OFF THE BALLOON DURING WITHDRAWAL OF THE DEVICE. THE STENT WAS BEING ATTEMPTED TO BE DEPLOYED BUT IT CAME OFF THE BALLOON AND HAD TO RETRIEVED OUT OF THE VESSEL BY SNARE. ONE 3.0 X 22MM ONYX FRONTIER STENT WAS ALSO REPORTED TO BE COMING OFF THE BALLOON BUT WAS ABLE TO BE SUCCESSFULLY DEPLOYED AND IMPLANTED IN THE PATIENT. INTRAVASCULAR LITHOTRIPSY (IVL) WAS PERFORMED FIRST, THEN THE STENT CAME OFF THE NON-MEDTRONIC WIR

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 19990901 ↗
• InjuryAug 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT DURING A LEFT HEART CATHETERIZATION WITH POSSIBLE INTERVENTION. THE LESION WAS NOTED IN THE FIRST OBTUSE MARGINAL BRANCH. THE STENT WAS INSERTED INTO THE FIRST OBTUSE MARGINAL BRANCH, BUT THE WIRE WAS "INADVERTENTLY PULLED BACK" PRIOR TO STENT DEPLOYMENT. IT WAS OBSERVED ON LIVE FLUORO THAT THE STENT HAD COME OFF THE DELIVERY BALLOON. IT WAS POSSIBLE TO USE THE BALLOON TO DRAG THE STENT BACK INTO THE PATIENT'S RIGHT ARM (RADIAL ARTERY). A SNARE WAS USED TO GRAB THE BALLOON AND TO PULL IT BACK DOWN TO THE RIGHT FOREARM WHERE THE STENT NOW REMAINS. THE STENT WAS LEFT IN THE PATIENT. THE PATIENT WAS REPORTED TO HAVE GOOD OXYGEN SATURATION (SPO2) WHICH WAS NOTED ON THE PLETH TO THE RIGHT HAND AT THE END OF THE CASE. THERE WAS ADEQUATE ULNAR FLOW. THE PATIENT DENIED ANY PAIN OR NUMBNESS/TINGLING AT THE END OF THE CASE AND THE PATIENT'S HAND WAS WARM WITH GOOD COLORATION. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 19981336 ↗
• InjuryMay 9, 2024Device 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, MODERATELY CALCIFIED LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT A STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. ATTEMPTS WERE MADE TO RETRIEVE THE STENT BUT THE DISLODGED STENT WAS NOT REMOVED. THE DISLODGED STENT WAS CRUSHED TO THE VESSEL WALL USING ANOTHER STENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 19276898 ↗
• InjuryMay 8, 2024Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Deformation Due to Compressive Stress; 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 LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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 NOTED WHILE ADVANCING THE DEVICE AT THE LESION SITE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS ALSO REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. AFTER THE DELIVERY SYSTEM ENCOUNTERED RESISTANCE AT THE LESION SITE THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT WAS NO LONGER ATTACHED TO THE BALLOON. UPON ANGIO THE STENT WAS SEEN COMPLETELY UNRAVELED INSIDE THE ARTERY, AND WAS NOT RETRIEVABLE. THE DISLODGED STENT WAS NOT REMOVED AND THE PATIENT WENT TO SURGERY TO BYPASS THIS VESSEL. THE PATIENT IS ALIVE WITH INJURY.

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

  MAUDE report 19268213 ↗
• InjuryApr 8, 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED USING A SNARE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 19059930 ↗
• MalfunctionMar 4, 2024Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A LESION WITH HIGH GRADE STENOSIS IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS/POSITION THE LESION AND STENT DISLODGEMENT OCCURRED. IT WAS DETAILED THAT THE ONYX FRONTIER WAS ATTEMPTED TO BE DELIVERED IN THE LAD HOWEVER, IT WAS REMOVED FOR FURTHER PRE-DILATION OF THE LESION. AFTER PRE-DILATION WAS COMPLETE, IT WAS ATTEMPTED TO DELIVER THE STENT AGAIN. WHEN READY TO DEPLOY, IT WAS NOTED THAT THE STENT WAS NOT ON THE CATHETER. THE CATHETER WAS REMOVED AND THERE WAS NO STENT ON THE BALLOON. THE DISLODGED STENT DID NOT REMAIN IN PATIENT. IT WAS DETAILED THAT WHEN SEARCHING THE STERILE TABLE, THE STENT WAS FOUND LYING ON THE STERILE TABLE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825755 ↗
• MalfunctionFeb 19, 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT AS IT REMAINED IN THE GUIDE CATHETER AND WAS ABLE TO BE RETRIEVED FROM THE GUIDE UPON REMOVAL. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735474 ↗
• InjuryJan 17, 2024Positioning Problem; Positioning Problem

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

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 18523960 ↗
• InjuryDec 20, 2023Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID LEFT MAIN (LM) CORONARY ARTERY AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED.  NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PREDILATED. THE DEVICE PASSED 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 DETAILED THAT THE STENT DISLODGED WHILE ATTEMPTING TO PASS IT THROUGH A PREVIOUS STENT IN THE LM ARTERY. THE DISLODGED STENT WAS REMOVED WITH A SNARE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 18362067 ↗
• InjuryJun 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A CORONARY ANGIOPLASTY AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT THE STENT DISLODGED OFF THE BALLOON IN THE LAD. A SMALLER BALLOON WAS USED TO RETRIEVE THE STENT WITH NO COMPLICATIONS. IT WAS NOTED THAT ALL OF THE STENT WAS REMOVED FROM THE PATIENT. ANOTHER STENT WAS DEPLOYED WITHOUT ISSUES. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17080572 ↗
• DeathJan 5, 2023Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERELY CALCIFIED, SEVERELY TORTUOUS LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) 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. IT WAS REPORTED THAT THERE WAS BALLOON REMOVAL DIFFICULTIES AFTER STENT DEPLOYMENT, AND A CATHETER SHAFT BREAK OCCURRED. THE CIRCUMFLEX ARTERY HAD BEEN SUCCESSFULLY STENTED WITH TWO NON-MEDTRONIC (MDT) DES. THE LAD WAS CALCIFIED AND SHOCKWAVE LITHOTRIPSY WAS DONE. THERE WAS DIFFICULTY IN REMOVING THE LITHOTRIPSY SYSTEM. THE MID LAD WAS STENTED WITH A NON-MDT DES. THE PROXIMAL LAD WAS THEN STENTED WITH THE ONYX FRONTIER DES. POST STENT PLACEMENT THE ONYX FRONTIER BALLOON APPEARED STRETCHED OUT AND WOULD NOT RETRACT. ATTEMPTS WERE MADE TO REMOVE THE STENT CATHETER WITH A NON-MDT GUIDE EXTENSION CATHETER, BUT THE CATHETER PRESUMABLY BROKE, AS THE BALLOON APPEARED CAUGHT ON THE STENT SCAFFOLD. THE LAD BECAME OCCLUDED BY THE CATHETER/BALLOON AND THE PATIENT

  Patient problems: Arrhythmia; Insufficient Information; Ischemia; Myocardial Infarction; Obstruction/Occlusion; Shock

  MAUDE report 16109527 ↗
• MalfunctionSep 6, 2022Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation 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 NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THOUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED AND A BALLOON BURST OCCURRED DURING BALLOON INFLATION AT LOW ATM. UPON INFLATION OF THE BALLOON, IT WAS NOTED THAT THE CONTRAST WAS JUST SITTING AND THE BALLOON DID NOT INFLATE. THE STENT WAS SUCCESSFULLY DELIVERED TO THE LESION. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361917 ↗