Advanix™ Biliary M00532900Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729786818), received between Oct 26, 2020 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 12462977 ↗
• 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 MPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12462316 ↗
• MalfunctionFeb 10, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILIARY PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT FROM THE PATIENT, IT BECAME STRETCHED LIKE A SPAGHETTI NOODLE. REPORTEDLY, THE STENT BROKE INTO PIECES, IT IS UNKNOWN ON HOW THE BROKEN STENT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER FLEXIMA 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. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 10, 2021: THE ISSUE OCCURED DURING STENT REMOVAL PROCEDURE AND THE STENT WAS ENTIRELY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309547 ↗
• MalfunctionOct 26, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT. THE EXACT PROCEDURE DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020, APPROXIMATELY 4-6 WEEKS AFTER THE STENT WAS IMPLANTED, A PLANNED STENT EXCHANGE PROCEDURE WAS PERFORMED. WHEN THE PHYSICIAN WENT TO RETRIEVE THE PLASTIC STENT, IT BROKE IN THE SNARE AS HE TRIED TO PULLED IT OUT OF BILE DUCT. HE THEN WENT IN WITH FORCEPS AND IT BROKE INTO ANOTHER PIECE. ALL PIECES WERE RETRIEVED FROM PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10733170 ↗