Advanix™ Biliary M00533360Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729786733), received between Jan 6, 2021 and Jan 17, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY CENTER BEND STENT WAS TO BE USED TO TREAT A STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE DEVICE WAS OPENED; HOWEVER, UPON PLACEMENT, THE STENT BEGAN TO FALL APART. 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 18525683 ↗
• InjuryMay 27, 2021Adverse 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 IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING EMERGENT FOLLOW-UP, ON (B)(6) 2021, A DUODENAL BLEEDING WAS FOUND IN THE PATIENT AND THE PREVIOUSLY IMPLANTED STENT WAS 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 STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11891787 ↗
• InjuryJan 6, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY STENT WAS REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED IN THE COMMON BILE DUCT. THE IMPLANT DATE AND EXPLANT DATES WERE NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURE, IT WAS NOTICED THAT THE ADVANIX BILIARY STENT HAD MIGRATED DISTALLY AND PERFORATED THE DOUDENAL WALL. THE PERFORATION WAS CONFIRMED THROUGH ENDOSCOPY. THE MIGRATED STENT WAS REMOVED USING A PAIR OF BIOPSY FORCEPS AND THE PROCEDURE WAS COMPLETED. NO TREATMENT INFORMATION WAS REPORTED FOR THE PERFORATION. THERE WERE NO NEW STENT IMPLANTED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 11123713 ↗