Advanix™ Biliary M00534300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729787396), received between Oct 4, 2021 and Oct 30, 2025 — classified as 1 death, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2025Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDEWIRE WAS UNABLE TO EXIT THE RX PORT DESPITE MULTIPLE ATTEMPTS. THE DEVICE WAS REMOVED, AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE GUIDE CATHETER WAS SMASHED. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23429983 ↗
• InjuryMay 1, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS IMPLANTED TO TREAT A BILIARY STRICTURE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INTRODUCER DETACHED FROM THE DELIVERY SYSTEM AND REMAINED WITHIN THE STENT. THEY ATTEMPTED TO REMOVE INTRODUCER WITH FORCEPS, BUT THE INTRODUCER WOULD NOT EXIT THE DUCT WITHOUT TAKING THE STENT. THE DECISION WAS MADE TO LEAVE THE INTRODUCER WITHIN THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21945298 ↗
• InjuryMar 7, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE USED IN THE BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDE CATHETER SEPARATED FROM THE PUSH CATHETER WHEN THE DELIVERY SYSTEM WAS PULLED. THE DETACHED GUIDE CATHETER WAS REMOVED FROM THE PATIENT USING FORCEPS. ANOTHER ADVANIX-NAVIFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859520 ↗
• MalfunctionSep 29, 2023Break; Difficult or Delayed Positioning; Detachment of Device or Device Component; Break; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT AND NAVIFLEX RX DELIVERY SYSTEM WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE HANDLE WAS FOUND BROKEN, AND THE RELEASE MECHANISM OF THE DELIVERY SYSTEM WAS NOT FUNCTIONING PROPERLY. THERE WAS DIFFICULTY IN DEPLOYING THE STENT AND THE STENT AND GUIDE CATHETER WERE NOTICED TO BE BROKEN NEAR THE SHEATH. THE ADVANIX BILIARY STENT WAS IMPLANTED SUCCESSFULLY IN THIS PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: ITAS REPORTED THAT IT WAS THE HANDLE/RELEASE MECHANISM THAT WAS BROKEN AND NOT THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17845367 ↗
• DeathJul 20, 2022Use of Device Problem; Positioning Problem; Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS PLACED VIA PERCUTANEOUS CHOLECYSTOSTOMY DURING A PROCEDURE IN THE GALL BLADDER AND CYSTIC DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE PROXIMAL FLANGE GOT STUCK STUCK (MAY HAVE CAUGHT ON THE INTRODUCER SHEATH) WHICH PREVENTED THE STENT FROM DEPLOYING IN THE CORRECT POSITION. THE PHYSICIAN BELIEVED THAT THIS MAY HAVE CAUSED A PERFORATION OF THE GALL BLADDER RESULTING IN THE PROXIMAL END OF THE STENT DEPLOYED IN THE PERITONEUM. THE PATIENT WAS THEN REFERRED FOR A FOLLOW UP ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE TO PULL THE OTHER SIDE OF THE STENT FROM THE DUODENUM AND CORRECT THE STENT PLACEMENT. ON THE SAME DAY, THE FOLLOW ERCP WAS SUCCESSFULLY COMPLETED. POST PROCEDURE, THE PATIENT WOKE UP AND THEN WENT TO CARDIAC ARREST WHICH RESULTED TO DEATH. THE PHYSICIAN BELIEVED IT WAS DUE TO ANESTHETIC REACTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cardiac Arrest; Perforation

  MAUDE report 15065303 ↗
• MalfunctionOct 13, 2021Break; Positioning Failure; Device-Device Incompatibility; Material Deformation; Break; Positioning Failure; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILIARY SYSTEM PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS REPORTED THAT WHEN THEY TRIED TO DEPLOY THE STENT, THE HYDROPHILIC END OF THE JAGWIRE GOT CAUGHT IN THE GUIDE CATHETER AND BECAME BUNCHED UP, AND HAD TO PULL EVERYTHING OUT FROM THE PATIENT. THEREFORE, THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 12626757 ↗
• MalfunctionOct 4, 2021Break; Material Deformation; Material Split, Cut or Torn; Break; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX 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, BEFORE THE PHYSICIAN DEPLOYED THE STENT, IT WAS NOTICED THAT THE SUTURE WAS BROKEN. THE STENT COULD NOT BE DEPLOYED. ANOTHER ADVANIX RX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT WAS BROKEN AND DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12567083 ↗