Advanix™ Biliary M00533030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729786948), received between May 9, 2017 and Jan 12, 2023 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2023Adverse 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 USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE HEPATIC DUCT, PERFORMED ON (B)(6) 2022. POST PROCEDURE, THE PATIENT HAD EXPERIENCED BILIARY OBSTRUCTION. ON (B)(6) 2022, THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT. AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY FOR STENT REMOVAL PROCEDURE WAS PERFORMED ON (B)(6) 2022. THE STENT WAS SUCCESSFULLY REMOVED WITH A SNARE. TWO NEW ADVANIX BILIARY STENTS WERE IMPLANTED IN THE RIGHT AND LEFT HEPATIC DUCT. PUS WAS DRAINED FROM THE LEFT LOBE STENT AND BIOPSY AND BRUSHING WERE TAKEN FROM THE MASS IN THE BILIARY DUCT. ACCORDING TO THE PHYSICIAN'S ASSESSMENT THE STENT COULD HAVE BEEN THE CAUSE FOR THE OBSTRUCTION.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16150006 ↗
• MalfunctionMay 9, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT OF A PATIENT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, DIFFICULTY WAS EXPERIENCED WHEN THEY ATTEMPTED TO ADVANCE THE ADVANIX BILIARY STENT INTO THE PATIENT'S STRICTURE SITE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE 'GOOD'. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; STENT BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6554899 ↗