Advanix™ Biliary M00532970Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729786887), received between Dec 23, 2020 and Sep 13, 2021 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 12 most recent of 12 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 12463102 ↗
• 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 12461523 ↗
• 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 12458921 ↗
• 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 12458917 ↗
• 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 12458907 ↗
• 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 12458905 ↗
• 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 12458900 ↗
• MalfunctionSep 13, 2021Break; Difficult to Remove; Material Deformation; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available; Break; Difficult to Remove; Material Deformation; Material Integrity Problem; Appropriate Device Problem Term/Code Not Available

  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 PROCEDURE WAS CANCELLED DUE TO THIS EVENT AND IT WAS UNKNOWN IF THE PROCEDURE WAS RESCHEDULED. 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 KINKED, RIPPED AND A CHANGE OF COSMETIC APPEARANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12458888 ↗
• 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. 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. 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 12458670 ↗
• InjuryDec 23, 2020Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE DOUDENUM. THE PROCEDURE DATE WAS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PATIENT RETURNED TO THE HOSPITAL WITH SYMPTOMS OF PERFORATION. THE PERFORATION WAS CONFIRMED THROUGH ENDOSCOPY. ON (B)(6) 2020, AN ENDOSCOPIC CLOSURE PROCEDURE WAS PERFOMED, THE PHYSICIAN NOTICED THAT THE STENT MIGRATED DISTALLY AND WAS PUSHED BY THE STRICTURE INTO THE DOUDENAL WALL. THE MIGRATED ADVANIX BILIARY STENT WAS RETRIEVED WITH A PAIR OF FORCEPS AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO OTHER 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: Perforation

  MAUDE report 11066798 ↗
• InjuryDec 23, 2020Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE DUODENUM OF A PATIENT. AROUND MID (B)(6) THE PATIENT HAD THE BSC PLASTIC STENT IMPLANTED. HOWEVER, THE EXACT IMPLANT DATE WAS NOT REPORTED. ON (B)(6) 2020 THE PATIENT RETURNED FOR A PLANNED COMPUTERIZED TOMOGRAPHY (CT) SCAN FOR THE PATIENT'S UNDERLYING PANCREATIC CANCER. DURING THE CT SCAN, IT WAS NOTICED THAT THE BSC PLASTIC STENT HAD MIGRATED AND ERODED THROUGH THE DUODENAL WALL CAUSING A PERFORATION. THE PATIENT WAS SENT TO THE ENDOSCOPY PHYSICIAN WHERE THE MIGRATED STENT WAS REMOVED FROM THE PATIENT AND THE PERFORATION WAS CLOSED USING AN OVESCO DEVICE. THE PATIENT WAS RELEASED FROM THE HOSPITAL TWO DAYS LATER IN GOOD CONDITION. ABOUT A WEEK LATER, THE PATIENT WENT TO HOSPICE DUE TO THEIR UNDERLYING CANCER AND NOT DUE TO THE BSC PLASTIC STENT. THE PATIENT PASSED AWAY SHORTLY AFTERWARDS. THE EXACT DATE OF DEATH WAS NOT REPORTED. THE PHYSICIAN ASSESSED THAT THE PATIENT'S CAUSE OF DEATH WAS DUE TO THE UNDERLYING CANCER AND WAS NOT RELATED TO THE BSC PLASTIC STENT.

  Patient problems: No Code Available; Perforation

  MAUDE report 11066333 ↗
• InjuryDec 23, 2020Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE DOUDENUM. THE IMPLANT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN NOTICED THAT THE STENT MIGRATED DISTALLY AND WAS PUSHED DISTALLY BY THE STRICTURE INTO THE DOUDENUM WALL CAUSING PERFORATION. THE PERFOARTION WAS MANAGED BY THE PHYSICIAN SUCCESSFULLY. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Perforation

  MAUDE report 11066324 ↗