Advanix™ Biliary M00534280Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 08714729787372), received between Nov 22, 2016 and Jul 29, 2026 — classified as 8 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (20 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071247 ↗
• MalfunctionJun 2, 2026Break; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED TO THE BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE STENT BECAME LOOSE DURING PLACEMENT AND WAS DISLOCATED DURING DELIVERY. IN AN ATTEMPT TO RESOLVE THE ISSUE, THE PHYSICIAN TRIED TO ADVANCE THE GUIDING CATHETER TO MAINTAIN THE PROCEDURAL POSITION. HOWEVER, THIS WAS NOT SUCCESSFUL. AS A RESULT, THE PHYSICIAN HAD TO REMOVE THE STENT USING RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS NOT RETRACTED PRIOR TO DEPLOYMENT. HOWEVER, THE ADVANIX BILIARY STENT WITH DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "TO INITIATE DEPLOYMENT, ENSURE THE NAVIFLEX RX DELIVERY SYSTEM LOCKING MECHANISM IS UNLOCKED. RETRACT THE GUIDE CATHETER BY PULLING ON THE PULL WIRE CAP. THE STENT WILL BE RELEASED WHEN THE GUIDE CATHETER RO MARKER IS ALIGNED WITH THE PUSH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25368557 ↗
• MalfunctionFeb 2, 2026Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED IN THE DUCTUS CHOLEDOCHUS FOR A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN 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 CAN NOT BE FULLY DEPLOYED." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU. FURTHERMORE, IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE IFU, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE SNARE LOOP WAS DETACHED. PLEASE SEE BLOCK H10 FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24242307 ↗
• MalfunctionNov 25, 2025Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT COMMON BILE DUCT STONES IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT REACHED THE CORRECT POSITION IN THE COMMON BILE DUCT, BUT IT FAILED TO DEPLOY. ANOTHER ADVANIX-NAVIFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF GUIDE CATHETER DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649502 ↗
• MalfunctionOct 21, 2025Break; Difficult or Delayed Positioning; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Break; Difficult or Delayed Positioning; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED DB STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A STENOSIS OF UPPER COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS DIFFICULT TO DEPLOY THE STENT. THE SHEATH OF THE ADVANCER WAS PULLED TO DEPLOY; HOWEVER, THE POSITION OF THE STENT WAS STUCK WITH THE OTHER ONE. THE STENT WAS REMOVED WITH THE SNARE. THE DEVICE WAS INTENDED TO BE PRE-INSTALLED AND DEPLOYED AGAIN; HOWEVER, IT WAS NOTED THAT THE SHEATH WAS WRINKLED. ANOTHER OF THE SAME DEVICE WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: IT WAS REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU), "SLIDE THE STENT BARB COVER OVER THE TRAILING BARB, TO ASSIST WITH STENT INTRODUCTION INTO THE SCOPE." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU. NOTE: THIS COMPLAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23346619 ↗
• MalfunctionJul 14, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT AN OBSTRUCTION IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PROXIMAL FLANK OF THE STENT WAS NOTICED TO BE FRACTURED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON JULY 17, 2025. IT WAS CONFIRMED THAT THE STENT WAS BROKEN AND THERE WERE NO OTHER PROBLEMS NOTED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495472 ↗
• MalfunctionMar 10, 2025Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILIARY DUCT TO TREAT GALLBLADDER STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ADVANIX NAVIFLEX DELIVERY SYSTEM SNAPPED AND BROKE, AND THE STENT WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 CAN NOT BE FULLY DEPLOYED." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU. IT WAS ALSO REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. PER THE IFU, "SLIDE THE OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21566916 ↗
• InjuryNov 25, 2024Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE IMPLANTED IN THE BILIARY TRACT TO TREAT A BILE DUCT STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS NOTED TO BE DISLODGED, AND THE TIP PUNCTURED THE INTESTINAL TRACT, WHICH CAUSED PERFORATION. THE PERFORATION WAS ADDRESSED BY CLIP CLOSURE. THE STENT WAS DIFFICULT TO REMOVE BUT WAS EVENTUALLY REMOVED AFTER SEVERAL ATTEMPTS USING BODY FORCEPS. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Perforation

  MAUDE report 20771083 ↗
• InjuryNov 6, 2024Break; Positioning Failure; Use of Device Problem; Break; Positioning Failure; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED DOUBLE BEND STENT WAS USED TO TREAT A STRICTURE IN THE RIGHT HEPATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A FIRST ADVANIX BILIARY STENT WAS SUCCESSFULLY PLACED IN THE LEFT HEPATIC DUCT. HOWEVER, WHEN ATTEMPTING TO DEPLOY THE DEVICE INTO THE RIGHT HEPATIC DUCT, THE GUIDE CATHETER BECAME STUCK. DESPITE ADVANCING AND PUSHING THE STENT DEEPER INTO THE DUCT, ALONG WITH MOVEMENTS OF THE ELEVATOR AND SCOPE, THE GUIDE CATHETER DID NOT MOVE. SUBSEQUENTLY, THE DELIVERY SYSTEM WAS REMOVED FROM THE SCOPE, AND IT WAS NOTED THAT THE GUIDE CATHETER TOGETHER WITH THE STENT WERE BROKEN. A FOREIGN BODY RETRIEVER WAS THEN USED TO REMOVE THE BROKEN GUIDE CATHETER TOGETHER WITH THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY PRELOADED STENT OF A DIFFERENT SIZE. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620427 ↗
• MalfunctionOct 25, 2024Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED STENT WAS TO BE IMPLANTED IN THE INFERIOR BILE DUCT TO TREAT A MALIGNANT TUMOR, AS INDICATED BY JAUNDICE, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING PREPARATION, AFTER UNPACKING, THE CONNECTION WIRE OF THE BILE DUCT STENT TIP BECAME DISCONNECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT WHICH REVEALED THE GUIDE CATHETER WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533007 ↗
• InjuryApr 10, 2023Break; Defective Device; Break; Defective Device

  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 BILIARY STENOSIS ON A PANCREATIC TUMOR PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, AFTER PLACING ONE 8.5 FRENCH PLASTIC STENT SUCCESSFULLY (STENT MANUFACTURER UNKNOWN) A SECOND STENT, AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE PLACE, HOWEVER, IT WAS IMPOSSIBLE TO PASS THE GUIDEWIRE INTO THE TIGHT STENOSIS. IT WAS DECIDED TO REMOVE THE ADVANTIX BILIARY STENT AND INSERT A METAL STENT. DURING THE REMOVAL, USING RAT TOOTH FORCEPS, THE INNER PIN OF THE ADVANIX BILIARY STENT BECOME STUCK IN THE TUMOR AND THE STENT WAS TORN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW ADVANIX BILIARY STENT. THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708127 ↗
• InjuryMar 16, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS SUCCESSFULLY IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN STENT WAS POSITIONED FOR DEPLOYMENT, THE PHYSICIAN RETRACTED THE DELIVERY SYSTEM AND THE GUIDE CATHETER DETACHED. THE DETACHED GUIDE CATHETER WAS REMOVED FROM THE PATIENT WITH FORCEPS. THE ADVANIX STENT WAS THEN IMPLANTED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE GUIDE CATHETER WAS DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552589 ↗
• MalfunctionSep 12, 2022Break; Entrapment of Device; Retraction Problem; Detachment of Device or Device Component; Difficult to Advance; Positioning Problem; Break; Entrapment of Device; Retraction Problem; Detachment of Device or Device Component; Difficult to Advance; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON HEPATIC, COMMON BILE DUCT AND LEFT HEPATIC DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN DEPLOYING THE STENT DUE TO THE PATIENT'S TORTUROUS ANATOMY AND AN OBSTRUCTION RIGHT BEFORE THE CYSTIC DUCT. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT INTO THE COMMON BILE DUCT AND THE LEFT HEPATIC DUCT WITH A LOT OF RESISTANCE, THE PULLWIRE CAP BROKE OFF AND THE PUSH CATHETER WAS BROKEN, ALSO, THE GUIDE CATHETER CAME OUT OF THE INSULATION. THE STENT WAS DEPLOYED USING THE TIP OF THE PULLWIRE HANDLE AND A PAIR OF BIOPSY FORCEPS WAS USED TO PUSH THE PLASTIC STENT OUT OF THE DUODENOSCOPE CHANNEL TO HELP POSITION THE STENT FOR DEPLOYMENT. HOWEVER, IT WAS NOTICED AFTER DEPLOYMENT THAT THE STENT TRAILING BARB WAS STUCK IN THE DUODENOSCOPE AND IT WAS TORN, AND THE STENT WAS FOUND NOT IN PLACE ANYMORE. THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN STENT AND THE DELIVERY SYSTEM ALONG WITH THE SCOPE. ANOTHER STENT OF THE SAME MODEL WAS SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15406679 ↗
• InjuryMay 31, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS INITIALLY IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2022. ON (B)(6) 2022, A PLANNED STENT REMOVAL PROCEDURE WAS PERFORMED. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT WITH A PAIR OF RAT TOOTH, THE STENT WAS DIFFICULT TO REMOVE AND A PART OF THE STENT TORE OFF AND WAS LEFT IN THE COMMON BILE DUCT. THE PROCEDURE WAS COMPLETED LEAVING THE BROKEN PIECE OF STENT IN THE PATIENT AND IT WAS REPORTED THAT THE PATIENT WAS REFERRED TO ANOTHER FACILITY TO PERFORM AN ADDITIONAL PROCEDURE OF SPHINCTEROTOMY BY DOING A BALLOON SWEEP TO REMOVE THE BROKEN BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14553107 ↗
• InjuryMay 15, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT FAILED TO DEPLOY AS IT GOT STUCK WHEN CROSSING THE STENOSIS. THE PHYSICIAN CUT THE GUIDE CATHETER WITH A PAIR OF FOREIGN BODY PLIERS AND WITHDREW THE DEVICE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14404095 ↗
• MalfunctionSep 9, 2021Break; Material Deformation; Material Split, Cut or Torn; Break; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT FAILED TO DEPLOY BECAUSE THE STENT WAS TORN. THE PHYSICIAN WITHDREW THE STENT AND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12446212 ↗
• MalfunctionJun 15, 2021Break; Positioning Failure; Retraction Problem; Break; Positioning Failure; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE LOWER BILE DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE STENT WAS POSITIONED THROUGH THE GUIDEWIRE AND A RELEASE WAS PERFORMED, IT WAS NOTED THAT THEY HAD DIFFICULTY RETRACTING THE PULLWIRE. IT WAS REPORTED THAT THE GUIDE CATHETER WAS DETACHED AND WAS ABLE TO REMOVE FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NON BSC DEVICE. 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. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11998391 ↗
• MalfunctionMay 20, 2021Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE LOWER COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE GUIDEWIRE WAS WITHDRAWN FOR STENT DEPLOYMENT. WHEN THE GUIDE CATHETER WAS PUSHED, THE PHYSICIAN HAD DIFFICULTY IN PULLING IT OUT FROM THE STENT. THE GUIDE CATHETER WAS PULLED WITH FORCE; HOWEVER, IT WAS DEFORMED AND BROKEN WHICH RESULTED IN THE EXPOSURE OF THE STEEL WIRE AND THE STENT DEVIATION. IT WAS REPORTED THAT THE BROKEN GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. 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 11861060 ↗
• MalfunctionMay 13, 2021Break; Positioning Failure; Positioning Problem; Break; Positioning Failure; Positioning Problem

  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. DURING THE PROCEDURE, THE PHYSICIAN FOUND THAT THE STENT COULD NOT BE DEPLOYED. WHEN ATTEMPTED TO RETRACT THE GUIDE CATHETER, IT CRACKED. IT WAS REPORTED THAT THE PHYSICICAN FORCIBLY PULLED OFF THE BROKEN GUIDE CATHETER AND IT REMAINED WITHIN THE PUSH CATHETER ENABLING THE DEVICE TO BE REMOVED IN ONE PIECE. 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 11817001 ↗
• MalfunctionJan 4, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE TRACT PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT COULD NOT DEPLOY. THE GUIDE CATHETER WAS TORN. THE BROKEN PIECE REMAIN WITHIN THE PUSH CATHETER ENABLING THE DEVICE TO BE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. 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; No Consequences Or Impact To Patient

  MAUDE report 11109261 ↗
• MalfunctionOct 19, 2020Migration; Migration

  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, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, A PLANNED STENT REMOVAL WAS PERFORMED ON (B)(6) 2020. DURING THE PROCEDURE, IT WAS NOTICED UNDER FLOUROSCOPY THAT THE STENT MIGRATED PROXIMALLY IN THE COMMON BILE DUCT. THE MIGRATED STENT WAS REMOVED WITH THE USE OF A SPYGLASS AND A SPYSNARE AND A METAL STENT WAS IMPLANTED IN ITS PLACE AS PLANNED BY THE PHYSICIAN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE METAL 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

  MAUDE report 10702132 ↗
• InjuryOct 12, 2020Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY STENT WAS REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2020. THE EXACT IMPLANT DATE WAS NOT PROVIDED. ACCORDING TO THE COMPLAINANT, DURING THE PLANNED STENT REMOVAL PROCEDURE ON (B)(6) 2020, IT WAS NOTICED THAT THE STENT HAD MIGRATED DISTALLY OUT OF THE DUCT AND PERFORATED THE OPPOSITE SIDE OF THE DUODENAL WALL . THE PHYSICIAN WAS ABLE TO REMOVE THE STENT FROM THE PATIENT. NO NEW STENTS WERE IMPLANTED DURING THIS PROCEDURE. TREATMENT INFORMATION FOR THE PERFORATION AND CURRENT PATIENT STATUS WAS NOT REPORTED. 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: Perforation

  MAUDE report 10667217 ↗
• MalfunctionOct 9, 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 BILIARY TRACT, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS NOTICED THAT THE GUIDE CATHETER BROKE. THE BROKEN GUIDE CATHETER WAS PULLED OUT IN ONE PIECE. NO FRAGMENT WAS LEFT INSIDE THE PATIENT. ANOTHER ADVANIX RX BILIARY STENT WAS OPENED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10655517 ↗
• MalfunctionMay 4, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS NOTICED THAT A HAIRLIKE FOREIGN MATTER WAS PRESENT INSIDE THE STERILE BAG. ANOTHER ADVANIX-NAVIFLEX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. 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. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT A HAIRLIKE FOREIGN MATTER WAS PRESENT INSIDE THE STERILE BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10021546 ↗
• MalfunctionJan 15, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE LESION WAS CHOLEDOCHOLITHIASIS IN BILE DUCT. DURING THE PROCEDURE, AFTER REMOVING THE STONE, THE PHYSICIAN USED THE ADVANIX BILIARY STENT FOR DRAINAGE. WHILE DEPLOYING THE STENT, THE GUIDE CATHETER BROKE. THE BROKEN INNER GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. 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 Consequences Or Impact To Patient

  MAUDE report 9592318 ↗