Advanix™ Biliary M00534690Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729787242), received between Sep 22, 2017 and Dec 16, 2025 — classified as 6 injuries, 18 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. 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 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 A ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT A COLON CANCER DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) + ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. ANOTHER ADVANIX-NAVIFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE DEVICE ANALYSIS RESULTS; GUIDE CATHETER WAS DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23823480 ↗
• InjuryJun 26, 2025Break; Premature Activation; Break; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT A STONE IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT DETACHED FROM CATHETER PRIOR TO DEPLOYMENT AT THE TIP OF SCOPE. THE STENT WAS RETRIEVED WITH A SNARE. ANOTHER ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342519 ↗
• MalfunctionMar 26, 2025Break; Positioning Failure; Material Deformation; Break; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS IMPOSSIBLE TO PLACE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED REGARDING THE EVENT DESPITE GOOD FAITH EFFORTS. 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 21698385 ↗
• MalfunctionMar 25, 2025Break; Activation, Positioning or Separation Problem; Break; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SUTURE COULD NOT BE RELEASED. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS 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 21690196 ↗
• MalfunctionMar 19, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE DUODENUM TO TREAT COMMON BILE DUCT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PULL WIRE WAS RETRACTED TO DEPLOY THE STENT. HOWEVER, THE INNER BLACK CATHETER COULD NOT BE REMOVED FROM INSIDE THE STENT, AND IT WAS NOTED THAT THE PULL WIRE WAS DETACHED FROM THE INNER BLACK CATHETER. THE DEVICE WAS REMOVED, AND ANOTHER OF THE SAME DEVICE WAS USED TO 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 21644570 ↗
• MalfunctionMar 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED CENTER BEND STENT WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE FLANGE ON THE BACK OF THE STENT BECAME CAUGHT IN THE ELEVATOR OF THE SCOPE. THE STENT AND THE SCOPE HAD TO BE REMOVED, AND ANOTHER ADVANIX BILIARY STENT WAS USED TO 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 21528660 ↗
• MalfunctionSep 3, 2024Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE DEPLOYMENT STYLET WAS PULLED OUT, THE INNER SHEATH WAS RUPTURED. THE ADVANIX STENT WAS REMOVED UNDEPLOYED FROM THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126794 ↗
• MalfunctionJul 2, 2024Entrapment of Device; Premature Activation; Use of Device Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Entrapment of Device; Premature Activation; Use of Device Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED STENT WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT AND DELIVERY SYSTEM WERE ADVANCED THROUGH THE BIOPSY CAP; HOWEVER, THE DELIVERY SYSTEM BECAME DIFFICULT TO ADVANCE. THE PHYSICIAN PULLED OUT THE DELIVERY SYSTEM AND NOTED THAT THE STENT WAS NO LONGER ATTACHED TO THE DELIVERY SYSTEM. THE STENT WAS FOUND INSIDE THE WORKING CHANNEL OF THE SCOPE. ANOTHER ENDOSCOPE WAS USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT, NOTE: THIS EVENT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE STENT BARB WAS TORN. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661263 ↗
• MalfunctionJul 2, 2024Entrapment of Device; Premature Activation; Use of Device Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Entrapment of Device; Premature Activation; Use of Device Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED STENT WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT AND DELIVERY SYSTEM WERE ADVANCED THROUGH THE BIOPSY CAP; HOWEVER, THE DELIVERY SYSTEM BECAME DIFFICULT TO ADVANCE. THE PHYSICIAN PULLED OUT THE DELIVERY SYSTEM AND NOTED THAT THE STENT WAS NO LONGER ATTACHED TO THE DELIVERY SYSTEM. THE STENT WAS FOUND INSIDE THE WORKING CHANNEL OF THE SCOPE. ANOTHER ENDOSCOPE WAS USED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. NOTE: THIS EVENT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE STENT BARB WAS TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661227 ↗
• MalfunctionJun 25, 2024Break; Positioning Failure; Retraction Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Retraction Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PULL WIRE WAS DIFFICULT TO RETRACT, AND THE STENT WOULD NOT SEPARATE AND DEPLOY FROM THE DELIVERY SYSTEM. THE GUIDEWIRE WAS THEN PULLED, BUT THE STENT STILL REMAINED ATTACHED TO THE DELIVERY SYSTEM. ANOTHER ADVANIX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 OUTER ORANGE SLEEVE OVER THE MOST PROXIMAL STENT BARB TO HOLD IT DOWN FOR STENT INSERTION." THE USER DID NOT FOLLOW THE IFU. 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610411 ↗
• InjuryJun 11, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED CENTER BEND STENT WAS USED IN THE BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE STENT WAS DEPLOYED, THE BLACK PORTION OF THE CATHETER BROKE OFF AND BECAME STUCK INSIDE THE STENT. THE STENT WAS SUCCESSFULLY PLACED, AND THE BLACK INNER CATHETER WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19514713 ↗
• MalfunctionMay 23, 2024Positioning 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 AND NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED IN THE D2 SEGMENT OF THE DUODENUM TO TREAT A STRICTURE DURING A BILE DUCT STRICTURE MANAGEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED EVEN THOUGH THE GUIDEWIRE WAS REMOVED. 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 BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "PULL BACK ON THE PULL WIRE CAP TO ADJUST THE LENGTH OF THE GUIDE CATHETER IN FRONT OF THE STENT, AND ENGAGE THE NAVIFLEX RX DELIVERY SYSTEM LOCKING MECHANISM. SLIDE THE STENT BARB COVER SO IT IS ON THE DISTAL END OF THE BLUE PUSH CATHETER NEAR THE STENT." THE PHYSICIAN DID NOT FOLLOW THE STEPS CITED IN THE IFU. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT BARB TORN. PLEASE SEE BLOCK H10 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387687 ↗
• MalfunctionApr 1, 2024Positioning Failure; Use of Device Problem; Component Missing; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Use of Device Problem; Component Missing; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY AND NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED IN THE COMMON BILE DUCT TO TREAT A STONE DISEASE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE NAVIFLEX DELIVERY SYSTEM DID NOT HAVE AN RO MARKER ON IT AND WAS NOT VISIBLE UNDER FLUOROSCOPY, AND THE STENT COULD NOT BE DEPLOYED. THE STENT AND DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT, AND 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 REPORTED THAT THE BARB FLAP COVER WAS NOT USED TO INSERT THE DEVICE THROUGH THE BIOPSY CAP. HOWEVER, THE ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM INSTRUCTIONS FOR US

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015505 ↗
• MalfunctionDec 8, 2023Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT 3005099803-2023-06521 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILITY STENT AND AN RX LOCKING DEVICE WERE TO BE USED IN THE PANCREATIC DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023, FOR TREATMENT OF CHRONIC PANCREATITIS. DURING THE PROCEDURE, RESISTANCE WAS FELT IN THE WORKING CHANNEL WHILE ADVANCING THE ADVANIX BILIARY STENT (THE SUBJECT OF THIS REPORT) THROUGH THE SCOPE DUE TO THE PEELED-OFF COVER OF THE GUIDEWIRE. CONSEQUENTLY, THE DISTAL END OF THE GUIDE CATHETER WAS SPLIT AT THE TIP. UPON VISUAL INSPECTION, IT WAS NOTED THAT THE SPONGE OF THE RX LOCKING DEVICE WAS DETACHED (THE SUBJECT OF MFR. REPORT # 3005099803-2023-06521). THE STENT AND THE LOCKING DEVICE WERE REMOVED FROM THE PATIENT AND EXCHANGED. ANOTHER ADVANIX BILIARY STENT WAS USED, AND A DIFFERENT LOCKING DEVICE WAS USED TO 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 18292251 ↗
• InjuryMar 24, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  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 (ERCP) PROCEDURE ON (B)(6) 2023, FOR TREATMENT OF BILIARY STONES. DURING DEPLOYMENT, THE NURSE RETRACTED THE PULL WIRE FORCEDLY AND THE GUIDE CATHETER DETACHED FROM THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED HOWEVER, THE GUIDE CATHETER REMAINED INSIDE THE PATIENT. THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16611954 ↗
• InjuryNov 30, 2022Break; Positioning Failure; Break; Positioning Failure

  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) 2022. DURING THE PROCEDURE AND INSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, IT WAS STUCK IN THE PUSH CATHETER. THE GUIDE CATHETER WAS DETACHED FROM THE DELIVERY SYSTEM AND FELL OFF HANGING ON THE COMMON BILE DUCT. THE BROKEN GUIDE CATHETER WAS REMOVED WITH THE USE OF A PAIR OF RAT TOOTH FORCEPS. ANOTHER ADVANIX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15884883 ↗
• MalfunctionJun 27, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A HEMOSTASIS PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT THE HANDLE COULD NOT BREAK THE STONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE REPORTED PROBLEM OF HANDLE COULD NOT BREAK THE STONE DOES NOT MATCH THE INTENDED USE OF THE COMPLAINT DEVICE; THEREFORE THE EXACT COMPLAINT EVENT IS UNKNOWN. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. 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 14830256 ↗
• MalfunctionMar 22, 2022Activation, Positioning or Separation Problem; Physical Resistance/Sticking

  ELDERLY MALE WITH HISTORY OF DIABETES MELLITUS (DM), HYPERTENSION (HTN), (CORONARY ARTERY DISEASE) CAD AND RECENT JAUNDICE AND POS LIVER FUNCTION TEST CONFIRMING BILIARY OBSTRUCTION. PROCEDURE: ENDOSCOPIC RETROGRADE WITH ANESTHESIA, CP/SPHINCTEROTOMY/STRICTURE BRUSHINGS, MASS BIOPSY AND STENT PLACEMENT. PROBLEM- WHILE DOING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) , THE WIRE WOULD NOT THREAD THROUGH THE STENT. IT FELT LIKE "HITTING A BRICK WALL". DEVICE REMOVED, ANOTHER ONE USED WITHOUT PROBLEMS. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CATHETER, BILIARY, DIAGNOSTIC, ADVANIX¿ BILIARY (PER SITE REPORTER). WILL OBTAIN AND REPLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13844679 ↗
• InjuryJan 21, 2020Break; Break

  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) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN INTRODUCED AN ADVANIX BILIARY STENT 10F(3,3MM)X 7CM, WHEN THE STENT WAS POSITIONED CORRECTLY AND THE PHYSICIAN STARTED TO RELEASE THE STENT. THEY REMOVED THE GUIDEWIRE AND UNBLOCKED THE NAVIFLEX SYSTEM, WHEN THEY RETRACTED THE PULL WIRE, THE GUIDE CATHETER WAS BROKEN INTO TWO PIECES AND THE BROKEN PIECE WAS STUCK IN THE STENT. THE BROKEN PIECE OF THE GUIDE CATHETER WAS RETRIEVED WITH A SNARE AND THE STENT WAS REMOVED UNINTENTIONALLY. ANOTHER ADVANIX BILIARY STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO SERIOUS INJURY, NOR WERE THERE ANY ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9613383 ↗
• MalfunctionJun 14, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING UNPACKING, IT WAS NOTICED THAT THE ADVANIX BILIARY STENT PACKAGING LABEL WAS TORN AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO ISSUE NOTED WITH THE OUTER FEDERAL EXPRESS BOX THAT THE DEVICE WAS SHIPPED IN. THERE WAS NO PATIENT OR PROCEDURE INVOLVED AT THE TIME THIS INCIDENT WAS NOTICED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8700765 ↗
• MalfunctionApr 15, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN COMMON BILE DUCT PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY FROM THE DELIVERY SYSTEM. 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 GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; GUIDE CATHETER BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515082 ↗
• MalfunctionOct 16, 2018Positioning 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 RX BILIARY STENT WAS USED DURING AN ENDOSCOPIC SPHINCTEROTOMY PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT IN THE COMMON BILE DUCT, IT DID NOT DEPLOY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT DEVICE OF A DIFFERENT MODEL. 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 RESULTS; GUIDE CATHETER BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7969827 ↗
• MalfunctionSep 20, 2018Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS REMOVED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE COMMON BILE DUCT ON (B)(6) 2018. THE STENT WAS REPORTEDLY PLACED A FEW WEEKS BEFORE THE PLANNED REMOVAL PROCEDURE, HOWEVER, THE EXACT IMPLANT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, DURING A PLANNED STENT REMOVAL, WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT USING A SNARE, THE STENT BROKE IN HALF. THERE WAS NO EXTRA DEVICE USED FOR THE RETRIEVAL. THE STENT WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7895568 ↗
• InjurySep 22, 2017Break; Break

  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) 2017. ACCORDING TO THE COMPLAINANT, DURING THE STENT REMOVAL PROCEDURE WHILE THE PHYSICIAN WAS REMOVING THE STENT, THE STENT BROKE INTO TWO PIECES. THE BROKEN PIECE WENT UP INTO THE COMMON BILE DUCT WAS REMOVED WITH A BALLOON EXTRACTOR AND THE PROCEDURE WAS COMPLETED. THE ENTIRE DEVICE WAS REMOVED WITH 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 6888570 ↗