Advanix™ Biliary M00534240Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729787334), received between Dec 14, 2018 and Oct 16, 2025 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WAS IMPLANTED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TIGHT PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE INSIDE THE ENDOSCOPE. THE PHYSICIAN USED A GRASPER TO REMOVE THE BROKEN GUIDE CATHETER FRAGMENT, AND THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY. REPORTEDLY, THE PROCEDURE WAS EXTENDED AS A RESULT OF THE ISSUE. HOWEVER, THERE WERE NO PATIENT COMPLICATIONS REPORTED. ***ADDITIONAL INFORMATION RECEIVED ON DECEMBER 11, 2025*** IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. PER THE IFU, "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED." THE USER DID NOT FOLLOW THE IFU; THEREFORE, THIS COMPLAINT HAS BEEN ASSIGNED AR CODE 5191: 2457 TO CAPTURE USER ERROR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23318777 ↗
• MalfunctionMar 21, 2025Entrapment of Device; Defective Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Entrapment of Device; Defective Device; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS IMPOSSIBLE TO PASS THE GUIDEWIRE THROUGH THE NORMAL ORIFICE IN THE STENT BECAUSE THERE WAS NO OPENING AT ALL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT ONE OF THE STENTS BARBS WAS TORN. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21664687 ↗
• MalfunctionMar 19, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, AND INSIDE THE PATIENT, THE GUIDE CATHETER BROKE INTO TWO PIECES. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21647086 ↗
• MalfunctionJul 12, 2024Unsealed Device Packaging; Packaging Problem; Unsealed Device Packaging; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS RECEIVED IN THE FACILITY. IT WAS REPORTED THAT THE PRODUCT WAS DAMAGED UPON ARRIVAL. A TEAR IN THE OUTER POUCH WAS NOTED, AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19734587 ↗
• MalfunctionApr 18, 2024Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS TO BE USED IN THE BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) / ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, THE GUIDE CATHETER DETACHED FROM THE DELIVERY SYSTEM AND GOT CAUGHT IN THE STENT. THE STENT REMAINS IMPLANTED, AND THE BROKEN GUIDE CATHETER WAS REMOVED BY LOCKING THE ELEVATOR ON THE GUIDE CATHETER WHILE REMOVING THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS INSIDE THE PATIENT DURING THE ATTEMPTED DEPLOYMENT. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "FOR PRELOADED SYSTEM ONLY: IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE ENDOSCOPE, THE STENT CANNOT BE FULLY DEPLOYED." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140446 ↗
• InjuryFeb 28, 2024Migration; Migration

  IT WAS REPORTED THAT AN ADVANIX BILIARY PRELOADED DOUBLE BEND STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT A TIGHT PROXIMAL STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE STENT WAS SUCCESSFULLY DEPLOYED DURING THE PROCEDURE. FORTY-EIGHT HOURS POST STENT PLACEMENT, THE PATIENT PRESENTED WITH A RIGHT UPPER QUADRANT PAIN AND WAS ADMITTED TO THE EMERGENCY ROOM. IMAGING SHOWED THAT THE STENT HAD MIGRATED DISTALLY OUT OF THE DUCT AND PERFORATED THE DUODENAL WALL. SUBSEQUENTLY, AN ENDOSCOPIC CLOSURE USING AN OVER THE SCOPE CLIP (OTSC) WAS DONE TO ADDRESS THE PERFORATION. THE STENT WAS ALSO REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 18803371 ↗
• InjuryDec 1, 2023Migration; Migration

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX-NAVIFLEX RX BILIARY STENTS WERE IMPLANTED IN THE RIGHT AND LEFT HEPATIC DUCTS TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, A DAY POST-STENT PLACEMENT, THE PATIENT EXPERIENCED PAIN. IMAGING WAS PERFORMED, AND IT WAS NOTED THAT ONE STENT MIGRATED AND PERFORATED THE DUODENUM, AND THE OTHER STENT ALSO MIGRATED. ON (B)(6) 2023, ANOTHER PROCEDURE WAS PERFORMED. THE STENTS WERE REMOVED USING RAT-TOOTH FORCEPS, AND THE PERFORATION WAS CLOSED USING AN OVESCO CLIP. NO ADDITIONAL STENTS WERE IMPLANTED IN PLACE OF THE MIGRATED STENTS. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT'S COMPLICATION IS RELATED TO THE DEVICE AND PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Pain

  MAUDE report 18250715 ↗
• InjuryDec 1, 2023Migration; Migration

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2023-06357 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX-NAVIFLEX RX BILIARY STENTS WERE IMPLANTED IN THE RIGHT AND LEFT HEPATIC DUCTS TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. ON NOVEMBER 2, 2023, A DAY POST-STENT PLACEMENT, THE PATIENT EXPERIENCED PAIN. IMAGING WAS PERFORMED, AND IT WAS NOTED THAT ONE STENT (THE SUBJECT OF THIS REPORT) MIGRATED AND PERFORATED THE DUODENUM, AND THE OTHER STENT (THE SUBJECT OF MFR. REPORT #3005099803-2023-06357) ALSO MIGRATED. ON (B)(6) 2023, ANOTHER PROCEDURE WAS PERFORMED. THE STENTS WERE REMOVED USING RAT-TOOTH FORCEPS, AND THE PERFORATION WAS CLOSED USING AN OVESCO CLIP. NO ADDITIONAL STENTS WERE IMPLANTED IN PLACE OF THE MIGRATED STENTS. IN THE PHYSICIAN'S ASSESSMENT, THE PATIENT'S COMPLICATION IS RELATED TO THE DEVICE AND PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Pain; Perforation

  MAUDE report 18247193 ↗
• InjuryJun 27, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT THE TWO ADVANIX BILIARY STENTS, SIZES 7FR 12CM AND 7F 15CM WERE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT. THE EXACT EVENT DATE IS UNKNOWN. THE PATIENT HAS A HISTORY OF CIRRHOSIS AND ORIENTAL CHOLANGIOPATHY WITH LARGE INTRAHEPATIC STONES. DURING EMERGENT FOLLOW UP, ON (B)(6) 2023, THE ADVANIX BILIARY STENT 7FR X 12CM HAS REMAINED IN THE DUCT WITHOUT ANY PROBLEM; HOWEVER, THE ADVANIX BILIARY STENT 7FR X 15CM HAD MIGRATED DISTALLY INTO THE DUODENAL WALL AND PERFORATED THE DUODENUM. AN UNPLANNED STENT REMOVAL WAS PERFORMED. THE MIGRATED STENT WAS RETRIEVED USING A SNARE AND THE PERFORATED DUODENAL WALL WAS TREATED VIA CLOSURE WITH A MANTIS DEVICE. THERE WAS NO NEW STENT IMPLANTED. ON (B)(6) 2023, THE PATIENT WAS DISCHARGED. THE PATIENT'S OUTCOME WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 17210667 ↗
• MalfunctionDec 31, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH PLASTIC STENT REMOVAL PROCEDURE IN THE BILE DUCT, PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, THE DISTAL END OF THE STENT TORE OFF AS HE PULLED IT OUT OF THE BILE DUCT WITH A SNARE. THE ADVANIX BILIARY STENT WAS REMOVED AND ANOTHER ADVANIX BILIARY 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 RIPPED/TORN. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13125480 ↗
• MalfunctionSep 20, 2021Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A COMMON BILE DUCT STRICTURE PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND OUTSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO USE THE STENT, IT WAS NOTICED THAT THE STENT DEPLOYED PREMATURELY TO THE WRONG POSITION. ANOTHER ADVANIX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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. 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 12494211 ↗
• MalfunctionNov 6, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT. THE PROCEDURE DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, A PLANNED STENT REMOVAL WAS PERFORMED ON (B)(6) 2020. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, IT WAS NOTICED THAT THE ADVANIX STENT WAS BROKEN AT THE DISTAL END. THE BROKEN PIECES OF STENT WERE RETRIEVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO NEW STENT WAS IMPLANTED. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10801361 ↗
• MalfunctionAug 8, 2019Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX NAVIFLEX BILIARY STENT WAS USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE RELEASED AND WAS FULLY REMOVED WITH THE CATHETER FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX NAVIFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE STENT DAMAGED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8875036 ↗
• InjuryDec 14, 2018Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE EXPLANTED DURING AN INTERVENTION RADIOLOGY/ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY PROCEDURE PERFORMED IN THE BILE DUCT ON (B)(6) 2018. THE ADVANIX BILIARY STENT WAS IMPLANTED IN THE PATIENT APPROXIMATELY TWO MONTHS PRIOR TO THE PLANNED REMOVAL PROCEDURE, HOWEVER, THE EXACT IMPLANT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018 DURING THE PLANNED STENT REMOVAL PROCEDURE, THE PHYSICIAN TRIED TO REMOVE THE STENT FROM THE BILE DUCT, BUT THE STENT STRETCHED OUT AND TORE. THE PHYSICIAN WAS NOT ABLE TO REMOVE THE STENT, SO INTERVENTIONAL RADIOLOGY WAS REQUIRED TO PLACE A PERCUTANEOUS DRAIN. THE PATIENT HAS BEEN REFERRED TO ANOTHER FACILITY FOR ADDITIONAL ENDOSCOPIC TREATMENT. THERE WERE NO SERIOUS INJURIES NOR WERE THERE ANY ADVERSE PATIENT EFFECTS 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 8165703 ↗