Advanix™ Biliary M00534320Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 08714729787419), received between Jan 6, 2017 and Apr 24, 2026 — classified as 11 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Break” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE BALLOON DILATION (ERBD) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PLASTIC STENT FAILED TO SEPARATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE IFU, "SLIDE THE STENT BARB COVER OVER THE TRAILING BARB TO ASSIST WITH STENT INTRODUCTION INTO THE SCOPE." THE USER DID NOT FOLLOW THE IFU. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983050 ↗
• InjuryMar 25, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS USED IN THE COMMON BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, UPON DEPLOYMENT OF THE STENT, THE BLACK INTRODUCER SEPARATED FROM THE DEVICE AND BECAME LODGED WITHIN THE STENT. THE PHYSICIAN THEN ADVANCED AN EGD SCOPE AND USED FORCEPS TO REMOVE THE SEPARATED INTRODUCER. THE STENT WAS LEFT IN PLACE AND REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688679 ↗
• InjuryJan 27, 2026Break; Adverse Event Without Identified Device or Use Problem

  NOTE: RELATED AXIOS COMPLAINT IS BEING REPORTED UNDER RECORD (B)(6). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE IMPLANTED TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE FIRST STENT; HOWEVER, THE INNER GUIDE CATHETER COMPLETELY BROKE APART. THE DEVICE SEPARATED INTO TWO OR MORE PIECES. THE PHYSICIAN THEN USED FORCEPS TO RETRIEVE THE BROKEN PIECES OF THE GUIDE CATHETER. A SECOND DEVICE WAS SUBSEQUENTLY USED, AND THE DEPLOYMENT CATHETER ALSO BROKE. IN THIS INSTANCE, THE DEVICE DID NOT SEPARATE INTO TWO OR MORE PIECES. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191027 ↗
• MalfunctionDec 4, 2025Break; Premature Activation; Adverse Event Without Identified Device or Use Problem; Break; Premature Activation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT CHOLEDOCHOLITHIASIS IN THE VATERI PAPILLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE INSERTION PROCESS, THE THREAD ON THE DELIVERY SYSTEM BECAME LOOSE WITHOUT ANY RETRACTION OF THE WIRE BY THE USER. AS A RESULT, THE STENT DETACHED PREMATURELY AND FELL OFF. ANOTHER ADVANIX-NAVIFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDINGS OF INNER GUIDE CATHETER DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717671 ↗
• MalfunctionAug 20, 2025Failure to Eject

  TWO 10F X 5CM ADVANTIX STENTS DID NOT DEPLOY AS EXPECTED (THE SECURED THREAD TO THE DEVICE DID NOT BREAK WHEN WIRE PULLED TO DEPOLY), A THIRD STENT DEPLOYED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850294 ↗
• MalfunctionAug 20, 2025Failure to Eject

  TWO 10F X 5CM ADVANTIX STENTS DID NOT DEPLOY AS EXPECTED (THE SECURED THREAD TO THE DEVICE DID NOT BREAK WHEN WIRE PULLED TO DEPLOY); A THIRD STENT DEPLOYED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850293 ↗
• InjuryAug 7, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO DEPLOY PROPERLY AS THE STENT INTRODUCER BEGAN TO SHEAR. THE STENT SYSTEM AND ALL PIECES WERE REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON AUGUST 21, 2025*** IT WAS REPORTED THAT THE ADVANIX BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A POTENTIAL LEAK. DURING PROCEDURE, THE GUIDE CATHETER BROKE AND WAS REMOVED USING A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745694 ↗
• MalfunctionSep 10, 2024Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY WITH RX DELIVERY SYSTEM WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, IT WAS NOTICED THAT THE STENT DID NOT HAVE A SUTURE ATTACHED TO IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT WHICH REVEALED THE STENT BARB WAS TORN. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20181424 ↗
• InjuryJul 12, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS USED IN THE COMMON BILE DUCT FOR ENDOSCOPIC RETROGRADE BILIARY DRAINAGE DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDE CATHETER BECAME DETACHED FROM THE DELIVERY SYSTEM AND WAS INADVERTENTLY DEPLOYED ALONG WITH THE STENT INTO THE COMMON BILE DUCT. THE DETACHED GUIDE CATHETER WAS REMOVED USING A RETRIEVAL LIGATER FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19735634 ↗
• MalfunctionMar 1, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. PRIOR TO THE PROCEDURE, BROWN SPOTS WERE NOTICED ON THE WHITE HANDLE UPON OPENING THE DEVICE. THE STERILE POUCH WAS REPORTED TO BE SEALED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822402 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS SUCCESSFULLY IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT THE INDICATION FOR PROCEDURE WAS PATIENTS REQUIRING PLACEMENT OF A PLASTIC STENT TO THE BILIARY TRACT FOR PROVIDING TREATMENT OF BILIARY STRICTURES, PATENCY TO AN IMPAIRED BILIARY DUCT, DRAINAGE OF THE BILE DUCT AND SPLINTING OF A BILE DUCT DURING HEALING. ON (B)(6) 2022 TO (B)(6) 2022, THE PATIENT WAS ADMITTED DUE TO FEVER AND RIGORS IN THE SETTING OF CURRENT ANTIBIOTIC TREATMENT FOR CHOLANGITIS WITH BILIARY STENT PLACEMENT FOR OBSTRUCTION RELATED TO PANCREATIC MALIGNANCY. THE PATIENT WAS GIVEN A MEDICATION OF CIPRO, CEFTRIAXONE AND METRONIDAZOLE. ON (B)(6) 2022, THE PATIENT WENT BACK AND WAS TRANSITIONED FROM CIPROFLOXACIN TO LEVOFLOXACIN. IT WAS NOTED THAT THE PATIENT UNDERWENT CT SCAN, AND A PANCREATIC MASS ENLARGEMENT WAS FOUND. ON (B)(6) 2022, IT WAS REPORTED THAT AN ADVANIX BILIARY STENT WAS SUCCESSFULLY REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE AND WAS REPLACED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: Cholangitis; Pain

  MAUDE report 15941018 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS SUCCESSFULLY IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2022. IT WAS REPORTED THAT THE INDICATION FOR PROCEDURE WAS PATIENTS REQUIRING PLACEMENT OF A PLASTIC STENT TO THE BILIARY TRACT FOR PROVIDING TREATMENT OF BILIARY STRICTURES, PATENCY TO AN IMPAIRED BILIARY DUCT, DRAINAGE OF THE BILE DUCT AND SPLINTING OF A BILE DUCT DURING HEALING. ON (B)(6) 2022, THE PATIENT UNDERGONE CHOLECYSTECTOMY DUE TO CHOLANGITIS FROM PEPTIC ULCER DISEASE. ON (B)(6) 2022, THE PATIENT EXPERIENCE PAIN AND HAD AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH STENT PLACEMENT. ON (B)(6) 2022, DURING THE PROCEDURE, IT WAS NOTED THAT PREVIOUSLY IMPLANTED STENT WAS SUCCESSFULLY REMOVED TO PREVENT BILIARY LEAK AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT.

  Patient problems: Cholangitis; Pain

  MAUDE report 15931797 ↗
• MalfunctionNov 4, 2022Positioning Failure; Positioning Failure

  NOTE: THIS REPORT IS ONE OF THREE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT #3005099803-2022-06245, AND MFR. REPORT #3005099803-2022-06270). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE ADVANIX BILIARY STENTS WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY PUSHING THE STENTS OUT OF THE ENDOSCOPE. THE PATIENT HAD A BILE DUCT ANOMALY AND THE PHYSICIAN DID NOT HAVE A GOOD VISION OF THE STENT GOING INTO THE BILE DUCT. A BLUE AREA WAS VISUALIZED ON THE SCREEN BUT THE PHYSICIAN COULD NOT DETERMINE IF THE FIRST STENT WAS DEPLOYED. IT APPEARED AS THOUGH A PART OF THE STENT MAY HAVE BEEN BLOCKING THE LENS VIEW. THE FIRST STENT WAS DEPLOYED PREMATURELY AND WAS THEN REMOVED FROM THE PATIENT. THERE WAS DIFFICULTY IN DEPLOYING THE SECOND STENT AS IT APPEARED LOST IN THE VIEW BUT WAS THEN SUCCESSFULLY DEPLOYED IN THE ANATOMY. THE PHYSICIAN REMOVED THE ENDOSCOPE AND THE THIRD STENT WAS SUCCESSFULLY DEPLOYED. AS A RESULT, THERE WAS AN APPROXIMATELY ONE AND A HALF HOUR SURGICAL DELAY AND THE INTENDED PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS SCHED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15729672 ↗
• InjuryMar 20, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, SEVERE RESISTANCE WAS FELT WHEN THE STENT WAS BEING PASSED THROUGH THE SCOPE AND WHEN IT CAME OUT OF THE SCOPE, THE FLANGE BROKE OFF. THE BROKEN PIECES OF STENT WAS SUCCESSFULLY RETRIEVED FORM THE PATIENT WITH A RETRIEVAL BASKET AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13831830 ↗
• InjuryOct 19, 2021Break; Positioning Failure; Retraction Problem; Break; Positioning Failure; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY AND BILIARY STENTING PROCEDURE IN THE PAPILLA DUDENI MAJOR AND COMMON BILE DUCT, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE AND INSIDE THE PATIENT, THERE WAS DIFFICULTY IN ADVANCING THE GUIDEWIRE AND WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE GUDE CATHETER WAS RIPPED OFF AND REMAINED IN THE COMMON BILE DUCT. ALL BROKEN PIECES OF GUIDE CATHETER WAS RETRIEVED WITH A USE OF SNARE AND ANOTHER ADVANIX-NAVIFLEX STENT WAS OPENED AND WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE GUIDE CATHETER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12661139 ↗
• MalfunctionSep 7, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS KINKED AND THE GUIDE CATHETER WAS BROKEN. ANOTHER ADVANIX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432357 ↗
• MalfunctionJun 23, 2021Break; Positioning Failure; Entrapment of Device; Material Deformation; Break; Positioning Failure; Entrapment of Device; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT, DIFFICULTY WAS NOTICED. THE GUIDE CATHETER WAS SHORTENED AND THE DISTAL TIP OF THE STENT KINKED DUE TO THE FORCE USED TO GET THE STENT UP THE BILE DUCT. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT BUT IT DEPLOYED PREMATURELY AND WAS STUCK INSIDE THE SCOPE. THE STENT WAS THEN PUSHED OUT OF THE SCOPE USING BIOPSY FORCEPS. A DIFFERENT DEVICE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. SUBSEQUENTLY, THE PHYSICIAN USED A SNARE TO GRAB AND RETRIEVE THE ORIGINAL ADVANIX STENT. WHEN ATTEMPTING TO PULL THE STENT THROUGH THE CHANNEL, THE STENT BROKE IN HALF. BOTH PIECES OF THE BROKEN STENT WERE THEN REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12048664 ↗
• MalfunctionApr 15, 2021Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS RECEIVED ON (B)(6) 2021. IT WAS REPORTED THAT THE STENT ARRIVED IN THE FACILITY WITH A HOLE IN THE PACKAGE AND THE STERILE BARRIER WAS COMPROMISED. THERE WERE NO PATIENT INVOLVEMENT AND THIS DEVICE WAS NOT USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672005 ↗
• MalfunctionFeb 22, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE STENT BARB WAS TORN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX-NAVIFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD AND STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359183 ↗
• MalfunctionOct 1, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE GUIDE CATHETER WAS COMPLETELY RETRACTED DURING THE STENT DEPLOYMENT ATTEMPT, HOWEVER THE SUTURE WAS STUCK BETWEEN THE PUSHER AND STENT WHICH CAUSES THE DEPLOYMENT FAILURE. REPORTEDLY, THE ENDOSCOPE WAS PULLED OUT OF THE PATIENT INCLUDING THE STENT AND DELIVERY SYSTEM AND IT WAS NOTICED THAT THE GUIDE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX-NAVIFLEX BILIARY STENT. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE AND GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9138714 ↗
• MalfunctionJul 15, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS REPORTED THAT THE SUTURE WAS SEPARATED FROM THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHE ADVANIX RX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE STENT SUTURE HOLE WAS TORN, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8789456 ↗
• InjuryJun 25, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN ATTEMPTED TO DEPLOY THE ADVANIX BILIARY STENT, THE GUIDE CATHETER WAS BROKEN AND REMAINED IN THE STENT, THE PHYSICIAN RETRIEVED THE BROKEN GUIDE CATHETER MANUALLY. THE PROCEDURE WAS COMPLETED WITH THIS ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8730711 ↗
• MalfunctionNov 12, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX STENT WAS USED DURING A CHOLANGIOSCOPY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS NOTICED THAT THE GUIDE CATHETER WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT DEVICE OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8061559 ↗
• MalfunctionOct 26, 2018Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; GUIDE CATHETER BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8009566 ↗
• MalfunctionJul 26, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ BILIARY STENT WAS USED FOR AN AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE WHEN THEY ATTEMPTED TO DEPLOY THE STENT IT WAS UNABLE TO RELEASE FROM THE PUSHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX¿ BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE". THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; GUIDE CATHETER BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7722344 ↗