Advanix™ Biliary M00534700Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729787259), received between Apr 13, 2017 and Jul 30, 2026 — classified as 11 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Break; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086832 ↗
• MalfunctionMar 11, 2026Break; 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 UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2026. THE CATHETER DETACHED FROM THE HOLDER, RESULTING IN A DELAY IN THE PROCEDURE; HOWEVER, THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24573015 ↗
• MalfunctionFeb 2, 2026Break; Positioning 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 TO BE IMPLANTED IN THE BILE DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE ADVANIX STENT INTO THE COMMON BILE DUCT, THE CATHETER CARRYING THE STENT COULD NOT BE RECAPTURED AND IT WAS ULTIMATELY TORN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24233320 ↗
• MalfunctionJan 6, 2026Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED FOR STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING STENT PREPARATION, THE NURSE ATTEMPTED TO RETRACT THE BLACK INNER CATHETER USING THE PULL WIRE. THE WIRE PULLED BACK, BUT THE INNER CATHETER DID NOT RETRACT. THE PULL WIRE WAS THEN PUSHED BACK IN AND THE ATTEMPT REPEATED; HOWEVER, THE CATHETER AGAIN DID NOT RETRACT. THE DEVICE WAS CONFIRMED TO BE IN THE UNLOCKED POSITION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23985502 ↗
• InjuryOct 27, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY CENTER BEND STENT PRELOADED WITH NAVIFLEX RX DELIVERY SYSTEM WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE AND REMAINED INSIDE THE STENT WHEN THE DELIVERY SYSTEM WAS REMOVED. THE BROKEN CATHETER WAS REMOVED USING A SNARE THROUGH THE PROXIMAL PORTION AND THE PROCEDURE WAS COMPLETED DESPITE THE DELAY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393170 ↗
• InjuryAug 5, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILIARY DUCT TO TREAT AN OBSTRUCTION DUE TO CHRONIC PANCREATITIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON JULY 15, 2025. THE PATIENT'S ANATOMY WAS NOT DILATED AND TORTUOUS. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED DURING STENT DEPLOYMENT, RESULTING IN THE DETACHMENT OF THE BLACK INTRODUCER FROM THE PUSHING COMPONENT OF THE DELIVERY SYSTEM. THE INNER GUIDE CATHETER FRACTURED INTO TWO PIECES. ATTEMPTS TO TROUBLESHOOT BY RETRACTING AND ADVANCING THE INTRODUCER VIA THE NAVIFLEX HANDLE WERE UNSUCCESSFUL. THE TEAM PROCEEDED TO REMOVE THE PUSHING CATHETER AND SUCCESSFULLY RETRIEVED BOTH THE STENT AND INTRODUCER USING A RAT TOOTH FORCEPS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE 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. PER THE IFU, "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22719739 ↗
• InjuryAug 5, 2025Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LITTLE PLASTIC BLUE PIECE AT THE END OF THE WIRE BROKE OFF, AND THE STENT DID NOT DEPLOY. IT WAS ALSO INDICATED THAT OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS WERE CONSIDERED OUTCOMES ATTRIBUTED TO THE ADVERSE EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: Insufficient Information

  MAUDE report 22719736 ↗
• MalfunctionNov 19, 2024Break; Positioning Failure; Entrapment of Device; Use of Device Problem; Activation, Positioning or Separation Problem; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Entrapment of Device; Use of Device Problem; Activation, Positioning or Separation Problem; Device-Device Incompatibility; 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 TO BE IMPLANTED IN THE BILE DUCT TO TREAT A BILE LEAK DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS NOT ABLE TO BE RELEASED. THE PHYSICIAN ATTEMPTED TO PULL THE GUIDEWIRE; HOWEVER, THE GUIDEWIRE WAS STUCK INSIDE THE STENT AND STENT CATHETER. THE GUIDEWIRE WAS NOT ABLE TO BE PULLED OUT EVEN AFTER ADDITIONAL MANIPULATION WHICH CAUSED THE GUIDEWIRE TO FRAY. THE WHOLE DEVICE TOGETHER WITH THE GUIDEWIRE WAS MOVED FROM THE PATIENT. AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE GUIDE CATHETER WAS DETACHED. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20724715 ↗
• MalfunctionJun 11, 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 DUODENUM FOR DILATATION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON MAY 01, 2024. DURING THE PROCEDURE, THE BLACK GUIDE CATHETER DID NOT GO INTO THE SHEATH. THE PULL WIRE WAS PULLED BACK BUT IT WAS VERY STIFF AND GOT STUCK. THE DEVICE WAS REMOVED, AND IT WAS NOTED THAT THE BLACK GUIDE CATHETER WAS DETACHED FROM THE PULL WIRE. ANOTHER ADVANIX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19515157 ↗
• InjuryMay 10, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOAD CENTER BEND STENT WAS IMPLANTED IN THE COMMON BILE DUCT FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. A FEW DAYS AFTER STENT PLACEMENT, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. ENDOSCOPIC REVIEW CONFIRMED THAT THE STENT HAD MIGRATED DISTALLY AND IMPACTED THE OPPOSING DUODENAL WALL CAUSING PERFORATION. SUBSEQUENTLY, A SURGICAL INTERVENTION WAS PERFORMED, THE PERFORATION WAS CLOSED, AND THE STENT WAS ALSO REMOVED. LASTLY, THE PATIENT WAS ADMITTED BEYOND THE STANDARD OF CARE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Abdominal Pain; Bowel Perforation

  MAUDE report 19294134 ↗
• InjuryMay 10, 2024Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOAD CENTER BEND STENT WAS IMPLANTED IN THE COMMON BILE DUCT FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. A FEW WEEKS POST-STENT PLACEMENT, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. SCANS CONFIRMED THAT THE STENT HAD MIGRATED TO THE HORIZONTAL PART OF THE DUODENUM (D3) AND IMPACTED THE LUMINAL WALL CAUSING PERFORATION. SUBSEQUENTLY, THE STENT WAS REMOVED SURGICALLY, AND THE PERFORATION WAS CLOSED. LASTLY, THE PATIENT WAS ADMITTED BEYOND THE STANDARD OF CARE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Abdominal Pain; Bowel Perforation

  MAUDE report 19294129 ↗
• InjuryMar 4, 2024Break; Difficult or Delayed Positioning; Detachment of Device or Device Component; Break; Difficult or Delayed Positioning; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY WAS IMPLANTED FOR STONE REMOVAL DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY PROPERLY. THE PATIENT EXPERIENCED TRAUMA WHEN THE STENT WAS ATTEMPTED TO BE DEPLOYED AND DISLODGED FROM COMMON BILE DUCT. THE STENT SUTURE WAS BROKEN AND PART OF IT WAS ATTACHED TO THE STENT INSIDE THE PATIENT'S BODY. THE BLACK CATHETER GUIDE CATHETER WAS DETACHED AND WAS REMOVED FROM THE PATIENT USING A PAIR OF RESCUE FORCEPS. THE STENT REMAINS IMPLANTED, AND PATIENT'S BLEEDING AND EDEMA RESOLVE ON ITS OWN. NOTE: A REVIEW OF THE PHOTOS OF THE COMPLAINT DEVICE PROVIDED BY THE COMPLAINANT REVEALED THE STENT WAS BROKEN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Swelling/ Edema

  MAUDE report 18827151 ↗
• InjuryFeb 16, 2024Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS TO BE USED IN THE BILIARY TREE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) - BILIARY PLASTIC STENT IMPLANT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE GUIDE CATHETER DETACHED FROM THE PUSH CATHETER DURING ATTEMPTED DEPLOYMENT. THE DETACHED GUIDE CATHETER WAS REMOVED USING RETRIEVAL FORCEPS AND THE PROCEDURE WAS COMPLETED USING ANOTHER 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

  MAUDE report 18720741 ↗
• InjuryDec 6, 2023Break; Difficult or Delayed Positioning; Break; Difficult or Delayed Positioning

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED CENTER BEND STENT WAS IMPLANTED IN THE AMPULLA OF VATER DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2023. THE INITIAL PLAN WAS TO PLACE TWO 10F X 9CM AND ONE 10F X 7CM ADVANIX STENTS INTO THE COMMON BILE DUCT. DURING THE PROCEDURE, AFTER THE FIRST 10F X 9CM STENT WAS SUCCESSFULLY DEPLOYED, THE SECOND STENT OF THE SAME SIZE WAS DEPLOYED. HOWEVER, THE PHYSICIAN OBSERVED THAT THE STENT FELT STIFFER AND ENCOUNTERED DIFFICULTY IN DEPLOYING. SUBSEQUENTLY, THE SECOND STENT WAS ABLE TO DEPLOY; HOWEVER, WHILE CHECKING THE STENT IN FULL VIEW AFTER DEPLOYMENT, THE PHYSICIAN NOTED A BLACK TUBING WAS STILL ATTACHED TO THE STENT. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT IT WAS A PORTION OF THE DELIVERY SYSTEM THAT WAS DETACHED. A FORCEP WAS THEN INTRODUCED AND PULLED THE DETACHED PORTION OF THE DELIVERY SYSTEM; HOWEVER, IT CAUSED THE STENT TO MOVE SLIGHTLY OUT OF THE AMPULLA. DESPITE HAVING THE 10F X 7CM STENT BEING PREPARED FOR PLACEMENT, THE PHYSICIAN DECIDED NOT TO USE THE THIRD STENT DUE TO THE DIFFICULTY AND MOVEMENT OF THE SECOND STENT. THE STENTS R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278537 ↗
• MalfunctionSep 30, 2022Break; Break

  IT WAS REPORTED THAT A ADVANIX RX BILIARY DEVICE WAS ATTEMPTED TO BE USED FOR BILIARY STENTING PROCEDURE ON (B)(6). UPON OPENING THE DEVICE PACKAGE, THE NURSE FOUND THAT THE TIP OF THE GUIDE CATHETER WAS FRACTURED. AS A RESULT, THE DEVICE WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX RX BILIARY DEVICE. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE TIP OF THE GUIDE CATHETER WAS FRACTURED. 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 AS NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15511502 ↗
• MalfunctionJun 18, 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 BILE DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE GUIDE CATHETER REMAINED INSIDE THE STENT PREVENTING THE STENT TO BE DEPLOYED. IT WAS NOTICED THAT THE STENT BROKE INSIDE THE GUIDE CATHETER. THE BROKEN STENT WAS REMOVED WITHIN THE DELIVERY SYSTEM AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 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 14740038 ↗
• MalfunctionJul 1, 2021Break; Positioning Failure; Retraction Problem; Break; Positioning Failure; Retraction Problem

  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) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THERE WAS RESISTANCE IN RETRACTING THE PULLWIRE BUT IT WAS ABLE TO BE PULLED BACK FULLY. THE PHYSICIAN RETRACTED THE GUIDEWIRE AND NOTICED THAT THE STENT FAILED TO DEPLOY. UPON OBSERVATION ON THE CHOLANGIOGRAM, THE RO MARKER OF THE GUIDE CATHETER WAS STILL ABOVE THE STENT IN THE COMMON BILE DUCT. THE NAVIFLEX DELIVERY SYSTEM WAS ABLE TO BE REMOVED BUT THE STENT AND GUIDE CATHETER REMAINED THE COMMON BILE DUCT. THE PHYSICIAN MANAGED TO HAVE A SHORT SEGMENT OF THE STENT AND GUIDE CATHETER COME UP INTO THE SCOPE CHANNEL AFTER REMOVING THE DELIVERY SYSTEM AND WAS ABLE TO REMOVE THE STENT AND GUIDE CATHETER. 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. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THE GUIDE CATH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12101368 ↗
• MalfunctionJun 15, 2021Entrapment of Device; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT IS ONE OF THREE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2021-02498, MFR. REPORT # 3005099803-2021-02500 AND MFR. REPORT # 3005099803-2021-02501). 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, WHEN THE PHYSICIAN DELIVERED THE ADVANIX 12CM 10FR STENT INTO THE BILE DUCT, THE PHYSICIAN THAT THE STENT WAS TOO LONG AND NEEDED A SHORTER 9CM STENT. THE UNDEPLOYED ADVANIX-NAVIFLEX WAS REMOVED WITH SUTURE ATTACHED INTO SCOPE TO BE EXCHANGED WITH ANOTHER SHORTER 8.5FR 9CM ADVANIX PRELOADED STENT. THE PHYSICIAN ATTEMPTED TO INSERT THE 9CM STENT BUT STILL STRUGGLED TO COME OUT OF THE SCOPE INTO THE DUODENUM AND SO THEN EXCHANGED FOR ANOTHER 9CM 8.5 FR ADVANIX PRELOADED STENT WHICH ALSO STRUGGLED TO EXIT THE SCOPE. BOTH 9CM 8.5 FR ADVANIX PRELOADED STENT WAS ALSO REMOVED AND THEN IT WAS DISCOVERED THAT THE ORIGINAL 10FR 12CM STENT WAS DETACHED FROM THE DELIVERY SYSTEM IN THE SCOPE AND THE SUTURE STRING WAS BROKEN DURING REMOVAL AND WAS NOT NOTICED. THE ADVANIX 12CM 10FR STENT WAS

  Patient problems: Insufficient Information

  MAUDE report 12005302 ↗
• MalfunctionJun 15, 2021Entrapment of Device; Appropriate Device Problem Term/Code Not Available; Entrapment of Device; Appropriate Device Problem Term/Code Not Available

  NOTE: THIS REPORT IS ONE OF THREE COMPLAINTS THAT PERTAIN TO THE SAME EVENT (MFR REPORT # 3005099803-2021-02498, MFR. REPORT # 3005099803-2021-02500 AND MFR. REPORT # 3005099803-2021-02501). 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, WHEN THE PHYSICIAN DELIVERED THE ADVANIX 12CM 10FR STENT INTO THE BILE DUCT, THE PHYSICIAN THAT THE STENT WAS TOO LONG AND NEEDED A SHORTER 9CM STENT. THE UNDEPLOYED ADVANIX-NAVIFLEX WAS REMOVED WITH SUTURE ATTACHED INTO SCOPE TO BE EXCHANGED WITH ANOTHER SHORTER 8.5FR 9CM ADVANIX PRELOADED STENT. THE PHYSICIAN ATTEMPTED TO INSERT THE 9CM STENT BUT STILL STRUGGLED TO COME OUT OF THE SCOPE INTO THE DUODENUM AND SO THEN EXCHANGED FOR ANOTHER 9CM 8.5 FR ADVANIX PRELOADED STENT WHICH ALSO STRUGGLED TO EXIT THE SCOPE. BOTH 9CM 8.5 FR ADVANIX PRELOADED STENT WAS ALSO REMOVED AND THEN IT WAS DISCOVERED THAT THE ORIGINAL 10FR 12CM STENT WAS DETACHED FROM THE DELIVERY SYSTEM IN THE SCOPE AND THE SUTURE STRING WAS BROKEN DURING REMOVAL AND WAS NOT NOTICED. THE ADVANIX 12CM 10FR STENT WAS

  Patient problems: Insufficient Information

  MAUDE report 12005252 ↗
• MalfunctionMay 19, 2020Break; Break

  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) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN FELT SEVERE RESISTANCE WHILE ATTEMPTING TO RETRACT THE GUIDE CATHETER FOR STENT DEPLOYMENT. REPORTEDLY, THE STENT WAS UNABLE TO BE DEPLOYED AND IT WAS REMOVED ALONG WITH THE DELIVERY SYSTEM FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. 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 FINDING OF GUIDE CATHETER DETACHED/SEPARATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10071513 ↗
• InjuryAug 9, 2019Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PREVIOUSLY IMPLANTED ADVANIX BILIARY WAS REMOVED FROM A PATIENT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2019. THE EXACT IMPLANT DATE WAS NOT REPORTED. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019 THE PATIENT FELT UNCOMFORTABLE AND WAS ADMITTED TO THE HOSPITAL. DURING THE ERCP PROCEDURE, THE PHYSICIAN NOTED THAT THE ADVANIX BILIARY STENT HAD MIGRATED OUT OF THE BILE DUCT AND INTO THE DUODENUM, WHERE IT SUBSEQUENTLY CAUSED A PERFORATION IN THE DUODENUM NEAR THE AMPULLA. THE PATIENT WAS SENT TO SURGERY WHERE THE ADVANIX BILIARY STENT WAS REMOVED AND THE PERFORATION WAS CLOSED UP. ANOTHER STENT WAS PLACED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED. THE PATIENT'S CONDITION IS NOW REPORTED TO BE STABLE.

  Patient problems: Perforation

  MAUDE report 8880652 ↗
• InjuryOct 11, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREOTOGRAPHY (ERCP) PROCEDURE PERFORMED IN THE COMMON BILE DUCT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ADVANIX BILIARY STENT WAS IN POSITION FOR DEPLOYMENT, HOWEVER WHEN THE DELIVERY SYSTEM WAS RETRACTED, THE PHYSICIAN HEARD A 'SNAP', AND THE GUIDE CATHETER SEPARATED FROM THE DELIVERY SYSTEM. THE BROKEN GUIDE CATHETER AND THE STENT WERE REMOVED USING RAT TOOTH FORCEPS. 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".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6940919 ↗
• InjuryApr 13, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ BILIARY STENT WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED IN COMMON BILE DUCT ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE GUIDE CATHETER WAS BROKE FROM THE DELIVERY SYSTEM AND LEFT INSIDE THE PATIENT. THE BROKEN GUIDE CATHETER WAS REMOVED WITH A SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6491084 ↗