Onyx Frontier™ ONYXNG20030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000511173), received between Jul 24, 2023 and Aug 7, 2026 — classified as 9 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 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 80% stenosis located in the 1st Diagonal artery. Two Onyx Frontier were also implanted in the 1st Diagonal during a second intervention on the same day post the index procedure. Approximately 1 month post the index procedure, the CEC adjudicated that the patient suffered from acute lesion thrombosis, ARC definite.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 50170431 ↗
• InjuryFeb 25, 2026Device 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 DELIVERY TO/AT THE LESION. THE LESION BEING TREATED WAS LOCATED IN THE OSTIUM OF THE RIGHT CORONARY ARTERY (RCA). THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER MANAGEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Device Embedded In Tissue or Plaque

  MAUDE report 24440276 ↗
• MalfunctionNov 13, 2025Entrapment of Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Entrapment of Device; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT DISLODGED DURING DELIVERY TO/AT LESION. THE LESION BEING TREATED WAS NON-TORTUOUS, MODERATELY CALCIFIED WITH 70% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH A 2.25 X 15MM NON-MEDTRONIC BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT TO THE LESION. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. AN ATTEMPT WAS MADE TO DELIVER A 2.2 5X 38 NON-MEDTRONIC STENT BUT IT WOULD NOT CROSS THE LESION. A 6FR NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WAS INSERTED. THE 2.0 X 30MM ONYX FRONTIER STENT WAS INSERTED BUT WHEN ATTEMPTING TO CROSS THE LESION, RESISTANCE WAS NOTED. THE STENT DELIVERY CATHETER WAS REMOVED BUT THE STENT WAS NOT IN PLACE. FLUOROSCOPY REVEALED THAT THE STENT HAD DISLODGED AND WAS VISUALISED IN THE DISTAL PORTION OF THE NON-MEDTRONIC GEC. THE STENT WAS REMOVED INTACT WITH THE NON-MEDTRONIC GEC. A NEW NON-MEDTRONIC GEC WAS INSERTED AND THE INITIAL 2.25X38MM NON-MEDTRO NIC STENT WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542066 ↗
• MalfunctionJul 14, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT, THE STENT DISLODGED DURING DELIVERY TO/AT THE LESION. THE LESION BEING TREATED WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS. 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. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVELY PREPPED WITH NO ISSUES NOTED. THE STENT WAS ABLE TO BE SUCCESSFULLY DEPLOYED, DESPITE THE DISLODGMENT AND IMPROVED FLOW WAS ESTABLISHED. THE PATIENT WAS AGITATED AND MOVING VERY FREQUENTLY DURING THE PROCEDURE. THE PHYSICIAN ATTRIBUTED THE STENT DISLODGEMENT TO THE PATIENT'S FREQUENT MOBILITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493365 ↗
• InjuryMay 8, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION, AND ATTEMPTS TO SNARE THE STENT WERE UNSUCCESSFUL DUE TO VESSEL SIZE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED WITHOUT ISSUE. HOWEVER, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE STENT TO THE MID, NON-TORTUOUS SEGMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, THE STENT WAS REMOVED AND INSERTED A NON-MEDTRONIC CATHETER WITH THE STENT, BUT IT WAS UNSUCCESSFUL, AND STENT CAME OFF THE STENT BALLOON DURING REMOVAL OF THE UNDEPLOYED STENT. THE STENT BALLOON AND STENT DELIVERY CATHETER SYSTEM WAS SUCCESSFULLY REMOVED FROM PATIENT, BUT THE UNDEPLOYED STENT REMAINED IN THE VESSEL OVER THE GUIDEWIRE. AN ATTEMPT TO INFLATE A 1.25MM BALLOON WITHIN THE DISLODGED STENT TO RETRIEVE IT, BUT THIS WAS UNSUCCESSFUL. ULTIMATELY, THE DISLODGED STENT WAS CRUSHED AGAINST THE VESSEL WALL USING A BALLOON, AND A SECOND STENT WAS DEPLOYED TO COVER THE AREA. THE PATIENT REMAINED STABLE, AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

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

  MAUDE report 21989367 ↗
• MalfunctionMar 12, 2025Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; 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. A NON-MEDTRONIC WIRE WAS USED AND THE OLD STENT WAS PRE-DILATED. THERE WAS LOTS OF CALCIUM NOTED ON THE DISTAL EDGE OF THE OLD STENT. IT WAS BELIEVED THAT THE ONYX FRONTIER STENT JUST HIT THE STRUTS OF THE OLD STENT WHICH DEFORMED THE STENT. THE LESION BEING TREATED WAS A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL CIRCUMFLEX ARTERY (CX). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER 2.0 X 30MM 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 21584779 ↗
• MalfunctionMar 7, 2025Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY STENT, STENT DEFORMATION OCCURRED DURING AN ATTEMPT TO REMOVE THE DEVICE. THE LESION WAS MILDLY TORTUOSITY AND MILDLY CALCIFICATION WITH 99% STENOSIS IN THE OSTIUM AND PROXIMAL OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED PRIOR TO USE 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. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21545813 ↗
• InjuryFeb 6, 2025Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT DURING THE REMOVAL OF ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT FOLLOWING A FAILED DELIVERY, THE STENT BECAME DISLODGED. THE LESION BEING TREATED WAS MODERATELY TORTUOUS, MODERATELY CALCIFIED AND LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DISLODGED STENT WAS NOT REMOVED BUT REMAINED IN THE BODY AT AN UNKNOWN LOCATION. THE DISTAL LAD NEEDED TO BE TREATED WITH A 2.0X20MM ONYX FRONTIER DEVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21320191 ↗
• InjuryNov 15, 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/AT THE LESION. THE DISLODGED STENT WAS REMOVED WITH AN ENDOVASCULAR SNARE WITHIN THE GUIDE CATHETER. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20693160 ↗
• InjuryAug 6, 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 PROXIMAL RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

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

  MAUDE report 19915741 ↗
• InjuryJun 26, 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 LESION IN THE OSTIUM / DIAGONAL BRANCH. 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 NOTED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS STATED THAT AFTER STENTING THE LEFT MAIN (LM) THE DIAGONAL WAS BALLOONED USING A 2X15MM BALLOON. IT WAS THEN ATTEMPTED TO DELIVER THE STENT, WHICH WAS DISLODGED WHILE GOING THROUGH THE LM STENT. IT WAS DETAILED THAT AN ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT USING A SNARE, HOWEVER, THIS WAS UNSUCCESSFUL, AND THE DISLODGED STENT REMAINS IN THE PATIENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 19613774 ↗
• MalfunctionApr 15, 2024Burst Container or Vessel; Entrapment of Device; Device Damaged by Another Device; Material Deformation; Positioning Problem; Burst Container or Vessel; Entrapment of Device; Device Damaged by Another Device; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND MAMMARY GRAFT. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT WOULDN'T PASS THE LESION ON THE FIRST ATTEMPT. AN ATTEMPT WAS MADE TO REMOVE THE STENT AND STENT DELIVERY SYSTEM (SDS), BUT THERE WAS DIFFICULTY REMOVING THE DEVICE FROM THE 0.014 RAPID EXCHANGE WIRE. UPON REMOVAL A PIECE OF THE WIRE FRAYED ON THE STENT. THE STENT, SDS AND WIRE WERE REMOVED. THE LESION WAS R EWIRED. THE STENT WAS INSPECTED AND LOOKED OK. THE STENT WAS RE-ADVANCED TO THE LESION OVER A NEW WIRE. INFLATION WAS ATTEMPTED, BUT THE BALLOON APPEARED TO BE RUPTURED. THE STENT AND SDS WERE REMOVED OVER A 0.014 RX WIRE. A NEW ONYXN20030UX WAS ADVANCED AND IMPLANTED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103470 ↗
• MalfunctionJan 15, 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. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND THE STENT SHEARED OFF THE DEPLOYMENT SYSTEM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18510214 ↗
• MalfunctionJan 4, 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 70% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445223 ↗
• InjuryDec 21, 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 LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. A SNARE WAS USED IN AN ATTEMPT TO REMOVE THE DISLODGED STENT HOWEVER, THIS WAS UNSUCCESSFUL. THE DISLODGED STENT REMAINS IN THE PATIENT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

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

  MAUDE report 18370969 ↗
• InjuryDec 15, 2023Fracture; Fracture

  AN ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) WAS IMPLANTED DURING AN INDEX PROCEDURE IN A MODERATELY TORTUOUS LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE PROCEDURE THREE OTHER ONYX FRONTIER DES WERE IMPLANTED, ONE IN THE MID LAD, ONE IN THE PROXIMAL LAD AND ONE IN THE PROXIMAL FIRST DIAGONAL. A 2.25X20MM NC EUPHORA BALLOON WAS ALSO USED DURING THE INDEX PROCEDURE. A RIGHT RADIAL ACCESS WAS USED. THE ONYX FRONTIER IMPLANTED IN THE DISTAL LAD WAS INSPECTED PRIOR TO USE 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE STENT WAS DEPLOYED TO 12 ATM FOR 16 SECONDS. THE DISTAL LAD WAS POST-DILATED WITH A BALLOON TO 16 ATM FOR 15 SECONDS, AND 12 ATM FOR 5 SECONDS. THERE WERE NO PROCEDURE AL COMPLICATIONS. NO OTHER MEDTRONIC DEVICES WERE USED DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY FOUR MONTHS LATER THE PATIENT PRESENTED WITH SYMPTOMS OF CHEST PAIN AND SHORTNESS OF BREATH. DURING AN ANGIOGRAM OF THE LEFT SYSTEM, IT WAS NOTED THAT THE DI

  Patient problems: Chest Pain; Dyspnea; Insufficient Information

  MAUDE report 18333663 ↗
• MalfunctionSep 18, 2023Device 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. THE PROTECTIVE SHEATH WAS REMOVED PER THE IFU. THE STENT WAS HANDLED DIRECTLY POST REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES. RESISTANCE WAS NOTED DURING DELIVERY. IT WAS REPORTED THAT THE STENT UNRAVELED AND PULLED APART WHEN PULLING THE STENT OUT THE BODY. THE STENT CAME OUT UNRAVELED. THE STENT WAS BEING REMOVED FROM THE PATIENT AS IT COULD NOT GET TO THE LESION AND FAILED TO CROSS. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. A LAUNCHER GUIDE CATHETER WAS ALSO USED DURING THE PROCEDURE. THERE IS NO COMPLAINT AGAINST THE LAUNCHER DEVICE. NO PATIENT INJURY REPORTED.

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

  MAUDE report 17763097 ↗
• MalfunctionAug 14, 2023Entrapment 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 MILDLY TORTUOUS, MODERATELY CALCIFIED LESION WITH 85% STENOSIS IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED BEFORE USE 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE STENT WAS BEING REMOVED AS IT COULD NOT PASS THE LESION. WHEN ATTEMPTING TO REMOVE THE DEVICE, IT GOT CAUGHT IN A NON MEDTRONIC GUIDE EXTENSION CATHETER AND THE STENT CAME OFF IN THE TOUHY. THE DISLODGED STENT WAS REMOVED FROM PATIENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17539101 ↗
• MalfunctionJul 24, 2023Device 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 (DES) AND ONE 6F TELESCOPE GUIDE EXTENSION CATHETER (GEC) TO TREAT A LESION. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. AN ATTEMPT WAS MADE TO DELIVER THE ONYX FRONTIER STENT HOWEVER, IT FAILED TO CROSS THE LESION. A SECOND ATTEMPT WAS MADE TO DELIVER THE STENT USING A TELESCOPE GEC. IT WAS DETAILED THAT THE STENT GOT CAUGHT WHEN IT WAS PULLED BACK INTO THE TELESCOPE ALONG THE GUIDEWIRE. WHEN THE TELESCOPE WAS REMOVED, THE DISLODGED STENT WAS FOUND ON THE TELESCOPE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17377220 ↗