Advanix™ Biliary M00532220Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729787006), received between Feb 6, 2019 and Nov 8, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2021Positioning Failure; Deformation Due to Compressive Stress; Material Deformation; Positioning Failure; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE STENT WAS ADVANCED OVER THE GUIDEWIRE AND THROUGH THE STRICTURE, THE NURSE ATTEMPTED TO DEPLOY THE STENT BUT MET A LOT OF RESISTANCE. THE PHYSICIAN ENSURED THE ELEVATOR AND SCOPE DIALS WERE RELAXED. THE NURSE ATTEMPTED TO PULL HARDER UNTIL THE PULL WIRE SEPARATED FROM THE CATHETER OUTSIDE THE SCOPE AND THE STENT FAILED TO DEPLOY. THE STENT AND DELIVERY SYSTEM WAS REMOVED AND ANOTHER ADVANIX-NAVIFLEX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770674 ↗
• MalfunctionDec 8, 2020Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY STENT WAS GOING TO BE REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. THE IMPLANT DATE WAS REPORTED TO BE IN (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURE, THE PHYSICIAN FOUND THAT THE STENT HAD MIGRATED IN THE DUODENUM. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10967966 ↗
• MalfunctionNov 5, 2020Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  BOSTON SCIENTIFIC CORPORATION RECEIVED SIX COMPLAINTS REGARDING SIX SEPARATE ADVANIX BILIARY STENT DEVICES INVOLVED IN SEPARATE PROCEDURES ON DIFFERENT PATIENTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SIX ADVANIX BILIARY STENTS WERE USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES PERFORMED IN THE COMMON BILE DUCT OF SIX DIFFERENT PATIENTS. THE SIX PROCEDURES WERE PERFORMED ON BETWEEN (B)(6). HOWEVER, THE EXACT IMPLANT DATES WERE NOT REPORTED. THE SIX PATIENTS UNDERWENT PLANNED STENT REMOVAL PROCEDURES PERFORMED BETWEEN (B)(6). THE EXACT PROCEDURE DATES WERE NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURES, THE PHYSICIAN FOUND THAT A DOUBLE PIGTAIL STENT HAD MIGRATED PROXIMALLY IN THE DUODENUM FOR EACH CASE. THE DEVICES WERE REMOVED AND THE PROCEDURES WERE CANCELLED/RESCHEDULED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. EACH PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791127 ↗
• InjuryApr 3, 2020Problem with Sterilization; Contamination /Decontamination Problem; Problem with Sterilization; Contamination /Decontamination Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY STENT WAS REMOVED FROM A PATIENT DURING A PLANNED BILIARY STENT PROCEDURE PERFORMED IN THE BILIARY TRACT ON (B)(6) 2020. ON (B)(6) 2020 THE ADVANIX BILIARY STENT WAS PLACED IN THE PATIENT WITH NO ISSUES REPORTED DURING PLACEMENT OF THE DEVICE. THIS COMPLAINT IS BEING REPORTED TO ADDRESS THE DEVICE DEFICIENCY EXPERIENCED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020 DURING THE PLANNED STENT REMOVAL PROCEDURE, THE PHYSICIAN ATTEMPTED TO PULL OUT THE ADVANIX BILIARY STENT IN ORDER TO INSERT A METALLIC STENT IN ITS PLACE, HOWEVER, THE ADVANIX BILIARY STENT BECAME DAMAGED DURING ATTEMPTED REMOVAL. THE REMOVAL AND EXTRACTION ATTEMPTS WERE REPEATED SEVERAL TIMES WITH A SNARE AND GRASPING FORCEPS, BUT DURING THIS TIME THE STENT WAS BROKEN. AS A RESULT, IT WAS DETERMINED THAT ALL THE PIECES OF THE BROKEN STENT HAD BEEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THIS ENDOSCOPE WAS ALLEGEDLY CLEANED, DISINFECTED AND STORED AFTER THE PROCEDURE. TWO DAYS LATER ON (B)(6) 2020, THE PHYSICIAN WAS USING THE SAME ENDOSCOPE THAT WAS USED DUR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9922365 ↗
• MalfunctionApr 3, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY STENT WAS REMOVED FROM A PATIENT DURING A PLANNED BILIARY STENT PROCEDURE PERFORMED IN THE BILIARY TRACT ON (B)(6) 2020. ON (B)(6) 2020 THE ADVANIX BILIARY STENT WAS PLACED IN THE PATIENT WITH NO ISSUES REPORTED DURING PLACEMENT OF THE DEVICE. THIS COMPLAINT IS BEING REPORTED TO ADDRESS THE DEVICE DEFICIENCY EXPERIENCED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020 DURING THE PLANNED STENT REMOVAL PROCEDURE, THE PHYSICIAN ATTEMPTED TO PULL OUT THE ADVANIX BILIARY STENT IN ORDER TO INSERT A METALLIC STENT IN ITS PLACE, HOWEVER, THE ADVANIX BILIARY STENT BECAME DAMAGED DURING ATTEMPTED REMOVAL. THE REMOVAL AND EXTRACTION ATTEMPTS WERE REPEATED SEVERAL TIMES WITH A SNARE AND GRASPING FORCEPS, BUT DURING THIS TIME THE STENT WAS BROKEN. AS A RESULT, IT WAS DETERMINED THAT ALL THE PIECES OF THE BROKEN STENT HAD BEEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED. THIS ENDOSCOPE WAS ALLEGEDLY CLEANED, DISINFECTED AND STORED AFTER THE PROCEDURE. TWO DAYS LATER ON (B)(6) 2020, THE PHYSICIAN WAS USING THE SAME ENDOSCOPE THAT WAS USED DUR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9922299 ↗
• MalfunctionFeb 6, 2019Break; Break

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT PLACEMENT PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE PIGTAIL END OF TWO ADVANIX STENTS BROKE IN HALF AND COULD NOT BE PLACED IN TO THE NAVIFLEX DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX-NAVIFLEX OF THE SAME SIZE AND MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310358 ↗
• MalfunctionFeb 6, 2019Break; Break

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT PLACEMENT PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE PIGTAIL END OF TWO ADVANIX STENTS BROKE IN HALF AND COULD NOT BE PLACED IN TO THE NAVIFLEX DELIVERY SYSTEM. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX-NAVIFLEX OF THE SAME SIZE AND MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8310344 ↗