Advanix™ Biliary M00534230Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729787327), received between Jan 3, 2017 and Jan 28, 2026 — classified as 1 death, 6 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT DID NOT RELEASE FROM THE DELIVERY DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205651 ↗
• DeathDec 4, 2025Break; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Break; Difficult to Remove; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  PROCEDURE SUMMARY: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WAS PERFORMED ON (B)(6) 2025, TO TREAT CHOLANGITIS ASSOCIATED WITH AN ANASTOMOTIC STENOSIS FOLLOWING ORTHOTOPIC LIVER TRANSPLANTATION (OLT). IT WAS REPORTED THAT THE PATIENT HAD BEEN DIAGNOSED WITH SEPSIS ONE DAY PRIOR TO THE ERCP PROCEDURE. DURING THE PROCEDURE, THE ANASTOMOTIC SITE WAS OBSERVED TO BE VERY TIGHT, RIGID, AND ANGULATED. EVENT SUMMARY AND PATIENT STATUS: FOLLOWING PLACEMENT OF A FIRST ADVANIX BILIARY STENT ACROSS THE STENOSIS, WITH DUODENAL BENDING, A SECOND ADVANIX BILIARY STENT WAS DEPLOYED ALONGSIDE IT, WITH THE PROXIMAL END POSITIONED AT THE ANASTOMOTIC STRICTURE IN THE SETTING OF THE TIGHT AND ANGULATED BILIARY ANASTOMOTIC STENOSIS. AFTER POSITIONING THE STENT OVER THE GUIDEWIRE AND ADVANCING IT PAST THE STRICTURE USING THE PUSHER, THE GUIDEWIRE WAS REMOVED, FOLLOWED BY ATTEMPTED WITHDRAWAL OF THE INNER INTRODUCER. DURING REMOVAL OF THE INTRODUCER, SIGNIFICANT FRICTION WAS ENCOUNTERED, AND THE INTRODUCER BECAME LODGED WITHIN THE STENT AND THE PATIENT. DESPITE ATTEMPTS TO OPTIMIZE THE TRACTION ANGLE AND ADJUST ENDOSCOPIC POSI

  Patient problems: Liver Failure; Perforation; Sepsis

  MAUDE report 23716124 ↗
• InjuryNov 17, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST-PROCEDURE DURING AN EMERGENT FOLLOW-UP, IT WAS NOTICED THAT THE ADVANIX STENT MIGRATED DISTALLY AND CAUSED A PERFORATION ON THE OPPOSING DUODENAL WALL. REPORTEDLY, THE STENT WAS REMOVED. THE PATIENT CONDITION AFTER REMOVAL WAS NOT REPORTED.

  Patient problems: Perforation

  MAUDE report 23576814 ↗
• MalfunctionFeb 25, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX STENT WAS IMPLANTED TO TREAT A STRICTURE IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THE STRICTURE WAS TIGHT. WHEN HE INTRODUCED THE STENT AFTER CANNULATING, HE HAD TO PULL THE STENT OUT AFTER IT WAS UNABLE TO PASS IT THROUGH. DILATION OF THE DUCT WAS CONDUCTED, AND ANOTHER STENT PLACEMENT ATTEMPT WAS MADE. THE STENT WAS THEN ABLE TO BE DEPLOYED BUT THE GUIDE CATHETER BROKE IN THE PROCESS. THE CATHETER WAS REMOVED, AND THE STENT REMAINS IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. NOTE: 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 21463871 ↗
• InjuryDec 30, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT OF A PEDIATRIC PATIENT TO TREAT AN ANASTOMOTIC STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. FORTY-EIGHT HOURS AFTER THE STENT PLACEMENT PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL AND REPORTED EXPERIENCING PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, AND IT WAS NOTED THAT THE PATIENT HAD PERFORATION. THE STENT WAS ALSO NOTED TO HAVE MIGRATED THROUGH THE DUODENAL WALL. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE AFTER UNDERGOING A REINTERVENTION PROCEDURE TO CLOSE THE PERFORATION. IN THE PHYSICIAN'S ASSESSMENT, THE DUODENAL PERFORATION IS RELATED TO THE STENT. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Pain; Perforation

  MAUDE report 21043487 ↗
• MalfunctionNov 8, 2023Component Missing; Component Missing

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE RO MARKER BAND WAS MISSING. THE PROCEDURE WAS COMPLETED USING ANOTHER ADVANIX-NAVIFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095195 ↗
• MalfunctionSep 20, 2023Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6), 2023. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. ANOTHER ADVANIX BILIARY STENT WAS OPENED AND USED TO SUCCESSFULLY COMPLETE 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 RESULTS; GUIDE CATHETER DETACHED/SEPARATED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785404 ↗
• MalfunctionAug 7, 2023Break; 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 THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO TREAT OBSTRUCTIVE JAUNDICE IN THE ORIFICE OF THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, THE GUIDE CATHETER WAS FRACTURED UPON DEPLOYING THE STENT. ANOTHER ADVANIX BILIARY STENT WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17469445 ↗
• MalfunctionMay 11, 2023Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT ON (B)(6) 2023. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE PUSH CATHETER KINKED, AND THE STENT FAILED TO DEPLOY. ANOTHER ADVANIX BILIARY STENT WAS OPENED AND USED TO SUCCESSFULLY COMPLETE 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 RESULTS; GUIDE CATHETER DETACHED/SEPARATED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913593 ↗
• MalfunctionApr 12, 2022Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WITH STENT PLACEMENT IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE ADVANIX BILIARY STENT, A LOT OF RESISTANCE WAS MET. THE PHYSICIAN TRIED TO CHANGE THE ANGLE OF THE SCOPE, HOWEVER, IT DID NOT HELP. WHEN THEY CONTINUED RETRACTING THROUGH THE RESISTANCE, THE PUSH CATHETER WAS BROKEN AND WAS SEVERELY KINKED. ALSO, IT WAS REPORTED THAT THE GUIDE CATHETER WAS BROKEN. THE MANGLED DELIVERY SYSTEM AND STENT WERE REMOVED FROM THE PATIENT WITHOUT USING A RETRIEVAL DEVICE. 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 14091496 ↗
• InjuryMar 16, 2022Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WAS USED DURING A STENT PLACEMENT PROCEDURE, PERFORMED ON (B)(6) 2022. POST PROCEDURE, ON (B)(6) 2022, THE PATIENT CAME TO THE EMERGENCY ROOM WITH PAIN AND FEVER. A CT SCAN WAS PERFORMED AND IT WAS NOTED THAT THE PLASTIC STENT PERFORATED THE DUODENUM WALL OPPOSITE OF THE AMPULLA. ON (B)(6) 2022, AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE WAS PERFORMED. THE PHYSICIAN PULLED THE STENT AND CLOSED THE PERFORATION WITH AN OVER THE SCOPE OVESCO CLIP. THERE WERE NO INFORMATION IF A NEW STENT WAS IMPLANTED TO THE PATIENT. THE PATIENT REMAINED IN THE HOSPITAL FOR OBSERVATION IN STABLE CONDITION. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Fever; Pain; Perforation

  MAUDE report 13789798 ↗
• MalfunctionOct 19, 2021Positioning Failure; Use of Device Problem; Material Split, Cut or Torn; Positioning Failure; Use of Device Problem; Material Split, Cut or Torn

  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) 2021. A (B)(6) YEARS OLD MALE PATIENT, HAD CHOLEDOCHOLITHIASIS AND HIGH JAUNDICE, WENT TO A PROCEDURE AND THE MULTIPLE STONES WERE REMOVED BY BASKET. DURING THE PROCEDURE, AFTER THE STENT WAS PLACED IN THE ANATOMY, THEY FOUND THAT THE STENT COULD NOT BE DEPLOYED. 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. NOTE: THE DEVICE EXPIRED ON MAY 1, 2021, BUT THE DEVICE WAS USED DURING A PROCEDURE ON (B)(6) 2021. INVESTIGATION RESULTS REVEALED THAT THE STENT WAS TORN, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657631 ↗
• MalfunctionAug 4, 2021Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS REPORTED WHEN STENT WAS RELEASED, THEY EXPERIENCED DIFFICULTY RETRACTING THE PULLWIRE AND THE STENT WAS BENT. ALSO, THE PULLWIRE CAP WAS DETACHED AND THE PULLWIRE WAS DISLODGED. THE STENT WAS FINALLY DETACHED FROM THE CATHETER, HOWEVER IT WAS NOT PLACED IN THE DESIRED ANATOMY SITE. 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 GUIDE CATHETER WAS BROKEN THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12273831 ↗
• MalfunctionNov 10, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT INSERTION PROCEDURE IN THE HEPATIC DUCT OF BILIARY TREE, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN DECIDED TO PLACE TWO ADVANIX STENTS IN THE RIGHT HEPATIC DUCT. THE PHYSICIAN PLACED TWO ADVANIX 12 CM STENTS. AFTER PLACING BOTH STENTS IN THE PATIENT, THE PHYSICIAN REPORTED THAT THE FINAL X-RAY PICTURES SEEMED TO SHOW THAT THE SECOND STENT PLACED WAS MUCH SHORTER IN LENGTH THAN THE INITIAL 12CM STENT THAT WAS PLACED. THE PHYSICIAN DECIDED TO LEAVE THE STENT AS IT WAS ABLE TO DRAIN THE DUCT AT THIS POINT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10818292 ↗
• InjuryAug 28, 2020Break; Break

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PREVIOUSLY IMPLANTED ADVANIX NAVIFLEX BILIARY STENT WAS REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ON (B)(6) 2020, TWO ADVANIX NAVIFLEX BILIARY STENTS WERE IMPLANTED SUCCESSFULLY. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL, WHEN THE PHYSICIAN ATTEMPTED TO PULL THE STENT WITH THE USE OF SNARE THROUGH THE ERCP SCOPE, IT BROKE THE STENT INTO TWO PIECES. THE SAME HAPPENED TO THE SECOND STENT. REPORTEDLY, THE PHYSICIAN CHOSE TO LEAVE THE BROKEN PIECE IN 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10468966 ↗
• InjuryAug 28, 2020Break; Break

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PREVIOUSLY IMPLANTED ADVANIX NAVIFLEX BILIARY STENT WAS REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2020. ON (B)(6) 2020, TWO ADVANIX NAVIFLEX BILIARY STENTS WERE IMPLANTED SUCCESSFULLY. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL, WHEN THE PHYSICIAN ATTEMPTED TO PULL THE STENT WITH THE USE OF SNARE THROUGH THE ERCP SCOPE, IT BROKE THE STENT INTO TWO PIECES. THE SAME HAPPENED TO THE SECOND STENT. REPORTEDLY, THE PHYSICIAN CHOSE TO LEAVE THE BROKEN PIECE IN 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. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10468683 ↗
• MalfunctionNov 30, 2018Break; Break

  IT WAS REPORTED TO BOSTON'S SCIENTIFIC THAT AN ADVANIX RX BILIARY STENT WAS EXPLANTED FROM THE PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING STENT REMOVAL, IT WAS NOTED THAT THE ADVANIX RX BILIARY STENT BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8121130 ↗
• InjuryJan 3, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ RX PRELOADED BILIARY STENT WAS REMOVED FROM A PATIENT DURING A PLANNED STENT REMOVAL PROCEDURE PERFORMED IN COMMON BILE DUCT ON (B)(6) 2016. ON (B)(6) 2016 THE ADVANIX BILIARY STENT WAS IMPLANTED IN THE PATIENT FOR 8 WEEKS TO HEAL A BILE LEAK. NO ISSUES WERE REPORTED WITH THE DEVICE DURING IMPLANTATION. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, DURING THE STENT REMOVAL PROCEDURE, THE STENT WAS IDENTIFIED IN THE DUODENUM AND WAS GRASPED ABOVE THE DISTAL FLANGE WITH RAT TOOTH FORCEPS. AS THE PHYSICIAN ATTEMPTED TO PULL THE STENT FROM DUCT, THE STENT STRETCHED AND RIPPED. A SNARE WAS USED TO VERY SLOWLY AND GRADUALLY REMOVE THE DAMAGED STENT FROM THE DUCT. 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 6217979 ↗