Advanix™ Biliary M00532190Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 08714729786986), received between May 22, 2018 and Dec 11, 2025 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Component Missing; Adverse Event Without Identified Device or Use Problem; Component Missing; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A BILIARY STRICTURE IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, COULD NOT FOUND THE X-RAY MARKER. ANOTHER ADVANIX-NAVIFLEX BILIARY STEN WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 20, 2026. IT WAS REPORTED THAT THE GUIDE CATHETER'S RADIOPAQUE MARKER CANNOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23778812 ↗
• InjurySep 15, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS IMPLANTED TO TREAT AN OBSTRUCTION CAUSED BY STONES IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST PROCEDURE, THE PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE DUE TO STENT MIGRATION IN THE CBD WALL, AND THE PHYSICIAN OBSERVED THAT THE STENT CURLED AND HAD PERFORATED THROUGH THE BILE DUCT. THE PHYSICIAN RECTIFIED THE PERFORATION DURING THE PROCEDURE. ALTHOUGH THE STENT WAS BELIEVED TO BE EXPLANTED DURING LAPAROSCOPIC CHOLECYSTECTOMY, DEFINITIVE CONFIRMATION REMAINS UNKNOWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT HAS FULLY RECOVERED AFTER THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 23057708 ↗
• MalfunctionJul 23, 2025Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT GALLSTONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. PRIOR TO THE PROCEDURE, UPON OPENING THE PACKAGE AND OUTSIDE THE PATIENT, THE SHEATH WAS OBSERVED TO BE ABNORMALLY KINKED. THE PHYSICIAN APPLIED MINIMAL FORCE, WHICH RESULTED IN IMMEDIATE DAMAGE TO THE PRODUCT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22580866 ↗
• MalfunctionMar 28, 2025Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BLACK INNER SHEATH WAS SEPARATED DURING DEPLOYMENT. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21725163 ↗
• MalfunctionMay 14, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY DOUBLE PIGTAIL STENT WAS TO BE IMPLANTED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING PREPARATION, THE STENT WAS NOTED TO BE BENT AND BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310745 ↗
• InjurySep 25, 2023Break; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Material Deformation; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2023-05051 AND MFR. REPORT # 3005099803-2023-05175). IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT AND NAVIFLEX DELIVERY SYSTEM WERE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE SECOND PART DUODENUM, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE GUIDE CATHETER DETACHED FROM THE PUSH CATHETER. A PIECE OF THE BROKEN GUIDE CATHETER WAS LEFT INSIDE THE STENT. THE PHYSICIAN SUCCESSFULLY IMPLANTED THE STENT LEAVING THE PIECE OF BROKEN GUIDE CATHETER INSIDE. IT WAS REPORTED THAT A FOLLOW UP PROCEDURE WAS PERFORMED, AND THE IMPLANTED ADVANIX BILIARY STENT (THE SUBJECT OF THIS REPORT) WITH THE BROKEN PIECE OF GUIDE CATHETER OF THE NAVIFLEX DELIVERY SYSTEM (THE SUBJECT OF MFR REPORT # 3005099803-2023-05175) WERE SUCCESSFULLY RETRIEVED FROM THE PATIENT. THERE WAS NO INFORMATION IF A 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 ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813713 ↗
• MalfunctionMay 9, 2023Break; Break

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2023-02341 AND MFR. REPORT # 3005099803-2023-02340). IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE PLACED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, OUTSIDE THE PATIENT, WHEN THE NURSE ATTEMPTED TO LOAD THE ADVANIX BILIARY STENT ONTO THE GUIDEWIRE, THE PROXIMAL END OF THE GUIDEWIRE PERFORATED THE STENT. A SECOND ADVANIX BILIARY STENT WAS OPENED, AND THE SAME INCIDENT OCCURRED OF THE PROXIMAL END OF THE GUIDEWIRE PERFORATED THE SECOND STENT. A THIRD ADVANIX BILIARY STENT WAS SUCCESSFULLY LOADED WITH ASSISTANCE FROM ANOTHER NURSE. THE THIRD ADVANIX BILIARY STENT WAS PLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899685 ↗
• MalfunctionMay 9, 2023Break; Break

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR. REPORT # 3005099803-2023-02340). IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE PLACED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, OUTSIDE THE PATIENT, WHEN THE NURSE ATTEMPTED TO LOAD THE ADVANIX BILIARY STENT ONTO THE GUIDEWIRE, THE PROXIMAL END OF THE GUIDEWIRE PERFORATED THE STENT. A SECOND ADVANIX BILIARY STENT WAS OPENED, AND THE SAME INCIDENT OCCURRED OF THE PROXIMAL END OF THE GUIDEWIRE PERFORATED THE SECOND STENT. A THIRD ADVANIX BILIARY STENT WAS SUCCESSFULLY LOADED WITH ASSISTANCE FROM ANOTHER NURSE. THE THIRD ADVANIX BILIARY STENT WAS PLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899682 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE BILIARY DUCT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS TRYING TO BACKLOAD THE ADVANIX BILIARY STENT PUSHER, THE PROXIMAL TAIL OF THE STENT PIGTAIL HAD A CUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139481 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE BILIARY DUCT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS TRYING TO BACKLOAD THE ADVANIX BILIARY STENT PUSHER, THE PROXIMAL TAIL OF THE STENT PIGTAIL HAD A CUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139480 ↗
• MalfunctionApr 19, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE BILIARY DUCT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS TRYING TO BACKLOAD THE ADVANIX BILIARY STENT PUSHER, THE PROXIMAL TAIL OF THE STENT PIGTAIL HAD A CUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139478 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE BILIARY DUCT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS TRYING TO BACKLOAD THE ADVANIX BILIARY STENT PUSHER, THE PROXIMAL TAIL OF THE STENT PIGTAIL HAD A CUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139476 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE BILIARY DUCT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS TRYING TO BACKLOAD THE ADVANIX BILIARY STENT PUSHER, THE PROXIMAL TAIL OF THE STENT PIGTAIL HAD A CUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. 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 GOOD. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE BILIARY DUCT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN BACKLOADED THE ADVANIX BILIARY STENT TO THE PUSHER; THEN, WHEN THE PHYSICIAN RELEASED THE STENT, IT WAS NOTICED THAT THE PROXIMAL TAIL OF THE STENT PIGTAIL HAD A CUT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139475 ↗
• MalfunctionFeb 7, 2022Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN OBSTRUCTIVE JAUNDICE PROCEDURE IN THE LOWER COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE ADVANIX BILIARY STENT WAS PLACED IN THE BILE DUCT, IT BECAME KINKED AFTER WITHDRAWING THE PUSH CATHETER. IT WAS NOTED THAT THEY HAD DIFFICULTY SEPARATING THE ADVANIX BILIARY STENT FROM THE PUSH CATHETER UPON REACHING THE END OF THE STENT. 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 STABLE. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS DAMAGED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470844 ↗
• MalfunctionDec 15, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) IN THE BILIARY TRACT PERFORMED ON (B)(6) 2021. DURING PROCEDURE, IT WAS REPORTED THAT THE ADVANIX BILIARY STENT BENDS AND BENDS WHEN TRIED TO PLACE IN THE BILIARY TRACT. 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 GOOD. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS DAMAGED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009752 ↗
• MalfunctionMay 11, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN UNKNOWN PROCEDURE. THE EXACT EVENT DATE WAS NOT PROVIDED. DURING THE PROCEDURE, WHEN THE PHYSICIAN TRIED TO INSERT THE STENT, IT COULD NOT PENETRATE THROUGH THE STENOSIS AND THE STENT WAS BROKEN. 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807481 ↗
• MalfunctionDec 14, 2020Migration; Migration

  NOTE: THIS REPORT PERTAINS TO A HOT AXIOS STENT AND AN ADVANIX BILIARY STENT THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS USED TO TREAT A PANCREATIC WALLED-OFF NECROSIS (WON) DURING AN AXIOS STENT PLACEMENT PROCEDURE IN CONJUNCTION WITH AN ADVANIX BILIARY STENT USED IN A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. THE STENTS WERE SUCCESSFULLY IMPLANTED. NO ISSUES WERE NOTED WITH THE DEVICES. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PERFORMED ON (B)(6) 2019, THE ADVANIX BILIARY STENT WAS FOUND TO HAVE MIGRATED BUT REMAINED WITHIN THE PATIENT. BOTH THE AXIOS AND THE ADVANIX BILIARY STENTS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11004288 ↗
• 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 AUGUST 1, 2020 TO AUGUST 30, 2020. HOWEVER, THE EXACT IMPLANT DATES WERE NOT REPORTED. THE SIX PATIENTS UNDERWENT PLANNED STENT REMOVAL PROCEDURES PERFORMED BETWEEN SEPTEMBER 15, 2020 AND OCTOBER 11, 2020. 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 10791139 ↗
• MalfunctionAug 31, 2020Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX NAVIFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE STENT AND THE DELIVERY DEVICE DAMAGED. THE STENT AND THE DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX NAVIFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. 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 10474542 ↗
• MalfunctionAug 11, 2020Appropriate Device Problem Term/Code Not Available; 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 (ERCP) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, A PROBLEM OCCURRED WITH THE DEVICE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THE EXACT NATURE OF THE DEVICE FAILURE WAS NOT REPORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS NOTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10391276 ↗
• MalfunctionAug 11, 2020Appropriate Device Problem Term/Code Not Available; 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 (ERCP) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, A PROBLEM OCCURRED WITH THE DEVICE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THE EXACT NATURE OF THE DEVICE FAILURE WAS NOT REPORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS NOTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10391262 ↗
• MalfunctionAug 11, 2020Appropriate Device Problem Term/Code Not Available; 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 (ERCP) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, INSIDE THE PATIENT, THERE WAS A PROBLEM OCCURRED UPON DEPLOYING THE DEVICE. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENTS CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS NOTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10391143 ↗
• MalfunctionAug 3, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS GOING TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE DEVICE WAS NOTED TO BE FRACTURED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY 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 NOTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359261 ↗
• MalfunctionDec 30, 2019Break; Break

  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) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE GUIDE CATHETER BROKE IN HALF. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9531978 ↗
• InjuryMay 22, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ BILIARY STENT WAS REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2018. ON (B)(6) 2018 THE ADVANIX¿ BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT. ACCORDING TO THE COMPLAINANT, IT WAS NOTICED THAT THE STENT WAS KINKED DURING DEPLOYMENT. AFTER 7 DAYS, THE BILIRUBIN LEVEL ELEVATED AND THE STENT WAS BLOCKED. THE DEVICE WAS REMOVED ON (B)(6) 2018 AND 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7533229 ↗