Advanix™ Biliary M00532960Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729786870), received between Feb 13, 2018 and Sep 13, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2021Break; Difficult to Remove; Material Deformation; Break; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT REMOVAL PROCEDURE IN THE BILE DUCT, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, THE ADVANIX STENT HAS BEEN GETTING STUCK OR STRETCHING AND TEARING. THE PHYSICIAN TRIED TO REMOVE THE STENT USING VARIOUS POSITIONS WITH THE SCOPE AND ELEVATOR BUT WAS DIFFICULT TO REMOVE AND WAS COMING APART WHILE RETRIEVING THE STENT. THE ADVANIX BILIARY STENT WAS REMOVED AND IT WAS UNKNOWN IF A NEW STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460060 ↗
• MalfunctionSep 13, 2021Break; Difficult to Remove; Material Deformation; Break; Difficult to Remove; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT REMOVAL PROCEDURE IN THE BILE DUCT, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, THE ADVANIX STENT HAS BEEN GETTING STUCK OR STRETCHING AND TEARING. THE PHYSICIAN TRIED TO REMOVE THE STENT USING VARIOUS POSITIONS WITH THE SCOPE AND ELEVATOR BUT WAS DIFFICULT TO REMOVE AND WAS COMING APART WHILE RETRIEVING THE STENT. THE ADVANIX BILIARY STENT WAS REMOVED AND IT WAS UNKNOWN IF A NEW STENT WAS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12458970 ↗
• MalfunctionSep 13, 2021Break; Difficult to Remove; Material Deformation; Material Integrity Problem; Break; Difficult to Remove; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT REMOVAL PROCEDURE IN THE BILE DUCT, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, THE ADVANIX STENT HAS BEEN GETTING STUCK OR STRETCHING AND TEARING. THE PHYSICIAN TRIED TO REMOVE THE STENT USING VARIOUS POSITIONS WITH THE SCOPE AND ELEVATOR BUT WAS DIFFICULT TO REMOVE AND WAS COMING APART WHILE RETRIEVING THE STENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE STENT WAS BROKEN, KINKED AND CHANGED OF COSMETIC APPEARANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12458899 ↗
• MalfunctionFeb 13, 2018Break; 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 ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO ADVANCE INTO THE COMMON BILE DUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX¿ 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 "FINE". INVESTIGATION RESULTS REVEALED THE STENT WAS BROKEN, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266888 ↗