Advanix™ Biliary M00532990Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729786900), received between Apr 13, 2021 and Apr 13, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT EXCHANGE IN THE AMPULLA, PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, THE ADVANIX BILIARY STENT 10X5CM WAS SUCCESSFULLY PLACED. IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE BILE DRAINED IN THE PERCUTANEOUS BILIARY DRAINAGE. THE PHYSICIAN WANTED TO REPLACE THE PLASTIC STENT WITH A FULLY COVERED METAL, A WALLFLEX BILIARY STENT. DURING THE WITHDRAWAL PROCEDURE, UPON REMOVING THE PLASTIC STENT FROM THE PATIENT, THE DISTAL FLANGE CUT THROUGH THE AMPULLA WITH A PIECE OF TISSUE THAT WEDGED BETWEEN THE FLANGE AND THE STENT BODY. THE TISSUE WAS CUT USING A PRECUT SPHINCTEROTOMY TO DISLODGE THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A COVERED METAL WALLFLEX 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 FULLY RECOVERED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11655903 ↗