Advanix™ Biliary M00534340Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 08714729787433), received between Jun 7, 2017 and May 6, 2026 — classified as 13 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Contamination; Packaging Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS RECEIVED ON (B)(6) 2026. IT WAS REPORTED THAT IN THE FRONT PART OF THE PACKAGE WAS DAMAGED UPON ARRIVAL AT THE HOSPITAL. THE INNER PACKAGING WAS OBSERVED TO BE CUT, AND AS A RESULT OF THE DAMAGE, THE STERILITY OF THE DEVICE WAS COMPROMISED. THERE WAS NO PATIENT INVOLVEMENT AS THE DEVICE WAS NOT USED DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25106471 ↗
• MalfunctionMar 11, 2026Break; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED STENT WAS INTENDED TO BE IMPLANTED IN THE DUODENAL PAPILLA TO TREAT BILIARY LITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. THE PATIENT'S ANATOMY WAS DESCRIBED AS TORTUOUS. DURING INSERTION OF THE DELIVERY CATHETER INTO THE PAPILLA, THE SUTURE WIRE CONNECTING THE STENT TO THE CARRYING CATHETER DETACHED PREMATURELY. UNDER NORMAL CONDITIONS, THIS SUTURE DETACHES ONLY AFTER THE GUIDEWIRE IS REMOVED; HOWEVER, IN THIS CASE, THE DETACHMENT OCCURRED BEFORE GUIDEWIRE WITHDRAWAL, PREVENTING THE STENT FROM BEING RELEASED. THE DURATION OF THE PROCEDURE WAS PROLONGED BY APPROXIMATELY TWELVE MINUTES. HOWEVER, IT REMAINS UNKNOWN WHAT DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574800 ↗
• MalfunctionOct 31, 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 BILIARY STENT AND NAVIFLEX RX DELIVERY SYSTEM WAS TO BE IMPLANTED TO TREAT STONES IN THE BILIARY DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. DURING THE PROCEDURE, IT WAS FOUND THAT IT WAS IMPOSSIBLE TO DEPLOY THE STENT. DESPITE APPROPRIATE PREPARATION AND ATTEMPTS TO PLACE THE DEVICE, DEPLOYMENT COULD NOT BE ACHIEVED. ANOTHER ADVANIX BILIARY STENT AND NAVIFLEX RX DELIVERY SYSTEM 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. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441627 ↗
• MalfunctionOct 8, 2025Break; Difficult or Delayed Positioning; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Break; Difficult or Delayed Positioning; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT DB STENT WAS IMPLANTED IN THE RIGHT HEPATIC DUCT TO TREAT A HEPATIC STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PULL WIRE WAS ATTEMPTED TO BE PULLED TO RELEASE THE STENT. HOWEVER, THE PULL WIRE WAS COMPLETELY WITHDRAWN BUT THE BLACK GUIDE CATHETER WAS DETACHED FROM THE DELIVERY SYSTEM. THE CATHETER WAS REMOVED FROM THE SCOPE, AND IT WAS NOTED THAT THE STENT REMAINED IN THE SCOPE. THE PHYSICIAN THEN DECIDED TO PUSH THE GUIDE CATHETER OVER THE SCOPE TO PUSH THE STENT UP INTO THE DUCT. THE DETACHED GUIDE CATHETER WAS THEN REMOVED TOGETHER WITH THE DELIVERY SYSTEM. THE STENT WAS SUCCESSFULLY PLACED PAST THE STRICTURE, AND THE PROCEDURE WAS COMPLETED. 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. 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."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23251264 ↗
• MalfunctionAug 20, 2025Break; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Break; 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 IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ADVANIX BILIARY STENT WAS RELEASED BUT THE NAVILFLEX DELIVERY SYSTEM GUIDE CATHETER REMAINED ATTACHED. IT WAS NECESSARY TO PULL AS IT WAS STUCK TO THE ENDOSCOPE. THE GUIDE CATHETER WAS THEN DETACHED, AND THE STENT WAS PUSHED BACK. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854186 ↗
• MalfunctionMay 27, 2025Break; Positioning Failure; Use of Device Problem; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation; Break; Positioning Failure; Use of Device Problem; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED DUODENAL BEND WAS USED TO TREAT A STRICTURE IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE GUIDE CATHETER WAS STUCK, AND THE SUTURE DID NOT COME OUT OF THE GUIDE CATHETER. ANOTHER ADVANIX BILIARY PRELOADED 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. 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 H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090227 ↗
• InjuryMay 21, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING STENT DEPLOYMENT, THE PULL WIRE WAS OBSERVED TO HAVE KINKED AND BUCKLED; HOWEVER, DEPLOYMENT CONTINUED BY PULLING THE PULL WIRE. THE PHYSICIAN BELIEVED THE DEPLOYMENT WAS SUCCESSFUL, BUT UPON WITHDRAWING THE SCOPE, THE GUIDE CATHETER BROKE AND REMAINED INSIDE THE PATIENT, ATTACHED TO THE STENT. THE PHYSICIAN REMOVED THE GUIDE CATHETER ALONG WITH THE STENT USING RAT-TOOTH FORCEPS AND THE PROCEDURE WAS THEN COMPLETED USING ANOTHER ADVANIX BILIARY STENT OF A DIFFERENT SIZE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: PHOTOS OF THE COMPLAINT DEVICE, PROVIDED BY THE COMPLAINANT, SHOW THE GUIDE CATHETER ATTACHED TO THE ADVANIX STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062863 ↗
• MalfunctionMay 13, 2025Break; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Positioning Problem; Break; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS IMPLANTED IN THE BILE DUCT TO TREAT TWO LARGE STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2025. DURING PROCEDURE, THE ADVANIX STENT DID NOT DEPLOY. THE TECH PULLED BACK ON PULL WIRE, BUT IT DID NOT RELEASE. TECH PULLED THE PULLWIRE BACK FURTHER AND FELT A SNAP. THE PHYSICIAN THEN MANIPULATED THE SCOPE, AND THE STENT WAS ABLE TO BE DEPLOYED. SCOPE WAS REMOVED FROM THE PATIENT AND WAS INSERTED BACK TO VISUALIZE THE STENT. HOWEVER, IT WAS NOTED THAT THE STENT HAD MIGRATED INTO THE BILE DUCT. FLUOROSCOPY HAD POOR IMAGING DURING THE ENTIRE PROCEDURE AND THE PHYSICIAN WAS UNABLE TO USE FLUOROSCOPY AT THE CONCLUSION OF THE PROCEDURE TO ASSESS STENT LOCATION AS THE FLUOROSCOPY SCREEN WAS NOT FUNCTIONING PROPERLY. THE PROCEDURE WAS COMPLETED, AND THE PATIENT IS COMING BACK IN TWO WEEKS FOR REPEAT STENT AND STONE REMOVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22014858 ↗
• InjuryMay 5, 2025Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE NAVIFLEX GUIDE CATHETER BROKE. THE DETACHED CATHETER WAS REMOVED USING A RETRIEVAL DEVICE, 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 21962828 ↗
• MalfunctionJan 23, 2025Break; Positioning Failure; Use of Device Problem; Defective Device; Detachment of Device or Device Component; Material Deformation; Break; Positioning Failure; Use of Device Problem; Defective Device; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED DOUBLE BEND STENT WAS USED IN THE HEPATIC HILUM FOR BILIARY DRAINAGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE WHEN THE STENT WAS BEING DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY PRELOADED STENT. 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 21225654 ↗
• InjuryDec 10, 2024Break; 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 A ADVANIX- NAVIFLEX RX BILIARY STENT WAS TO BE IMPLANTED IN THE BILE DUCT/ AMPULLA TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT WOULD NOT FULLY DEPLOY, AND THE GUIDE CATHETER BROKE OFF. A GRASPING FORCEPS WAS USED TO REMOVE THE BROKEN GUIDE CATHETER. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT, SHOWING THAT THE GUIDE CATHETER WAS DETACHED AND KINKED, AND THE PULL WIRE BENT. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 10, 2024. IT WAS REPORTED THAT THE STENT WAS DEPLOYED, BUT DURING REMOVAL OF THE DELIVERY SYSTEM, THE GUIDE CATHETER BROKE OFF AND HAD TO BE REMOVED USING GRASPING FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20897699 ↗
• MalfunctionSep 11, 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 WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE STENT, THE GUIDEWIRE WAS NOT RETRACTED, PREVENTING THE SUCCESSFUL DEPLOYMENT OF THE STENT. 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." THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE BASED ON THE INVESTIGATION RESULT WHICH REVEALED THE STENT BARB WAS TORN. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20194235 ↗
• MalfunctionAug 12, 2024Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO ADVANIX BILIARY STENTS WITH NAVIFLEX RX DELIVERY SYSTEM THAT WERE USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT# 3005099803-2024-03847 AND MFR REPORT# 3005099803-2024-03849 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE BILE DUCT TO TREAT A BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, UPON DEPLOYMENT OF THE STENT, THE GUIDE CATHETER BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967889 ↗
• MalfunctionAug 12, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO ADVANIX BILIARY STENTS WITH NAVIFLEX RX DELIVERY SYSTEM THAT WERE USED DURING THE SAME PROCEDURE. PLEASE REFER TO MFR REPORT# 3005099803-2024-03847 AND MFR REPORT# 3005099803-2024-03849 FOR THE ASSOCIATED DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE BILE DUCT TO TREAT A BILIARY OBSTRUCTION DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, UPON DEPLOYMENT OF THE STENT, THE GUIDE CATHETER BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967885 ↗
• MalfunctionJun 18, 2024Break; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Use of Device Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT FOR BILE DRAINAGE DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE BLACK GUIDE CATHETER WAS DETACHED. THE STENT WAS SUCCESSFULLY IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE DELIVERY SYSTEM 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 CANNOT 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. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562909 ↗
• InjuryApr 29, 2024Break; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem; Break; Difficult or Delayed Positioning; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT AND NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE COMMON BILE DUCT TO TREAT STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6), 2024. THE PATIENT'S ANATOMY WAS NOT TOO TIGHT. DURING THE PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY, SO KOCHER FORCEPS WERE USED, WHICH ALLOWED THE STENT TO BE RELEASED BUT CAUSED A PIECE OF THE GUIDE CATHETER TO BREAK OFF. EVENTUALLY, THE STENT WAS CORRECTLY PLACED, AND THE PIECE OF THE GUIDE CATHETER WAS REMOVED USING FOREIGN BODY FORCEPS. THE STENT REMAINS IMPLANTED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATION REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202363 ↗
• MalfunctionApr 8, 2024Break; Positioning Failure; Use of Device Problem; Break; Positioning Failure; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED IN THE BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED FROM THE DELIVERY SYSTEM. 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, " PRIOR TO DEPLOYMENT, COMPLETELY RETRACT GUIDEWIRE INTO ENDOSCOPE. WARNING: 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 USE (IFU) STATES, "UNLOCK THE GUIDEWIRE FROM THE RX LOCKING DEVICE. ADVANCE THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068254 ↗
• 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 17780596 ↗
• MalfunctionJun 16, 2023Break; Positioning Failure; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE USED TO TREAT BILIARY STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT AND PAPILLA, PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS REMOVED AND THE STYLET WAS PULLED TO RELEASE THE STENT, THE GUIDE CATHETER BECAME STUCK IN THE STENT. THE THREAD COULD NOT BE RELEASED, AND THE GUIDE CATHETER COMPLETELY DETACHED FROM THE PUSHER. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE THREAD WAS STILL ATTACHED TO THE STENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW ADVANIX BILIARY STENT. 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 FROM THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142619 ↗
• InjuryJun 12, 2023Migration; Migration

  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 ON AN UNKNOWN DATE. THE STENT WAS IMPLANTED FOR APPROXIMATELY ONE MONTH. DURING AN EMERGENT FOLLOW UP, THE STENT HAD MIGRATED DISTALLY INTO THE RECTUM AND CAUSED A PERFORATION. AN UNPLANNED STENT REMOVAL WAS PERFORMED, AND THE PERFORATED RECTUM WAS CLOSED LAPAROSCOPICALLY. THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 17113993 ↗
• InjuryJun 8, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT ONE ADVANIX BILIARY STENT WAS SUCCESSFULLY IMPLANTED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT WAS PRESENTED TO THE EMERGENCY DEPARTMENT WITH SHAKES AND PAIN WITH ONGOING CANCER DIAGNOSIS. A COMPUTED TOMOGRAPHY SCAN WAS PERFORMED, AND IT SHOWED TUMOR GROWTH AND ASCITES. ON (B)(6) 2023, AN ERCP WAS PERFORMED, AND THE ADVANIX BILIARY STENT WAS FOUND TO BE OCCLUDED. AN UNPLANNED STENT EXCHANGE WAS PERFORMED. THE OCCLUDED ADVANIX BILIARY STENT WAS REMOVED, AND A NEW ADVANIX BILIARY STENT WAS SUCCESSFULLY PLACED. THE PATIENT WAS GIVEN A MEDICATION OF ZOSYN, ACETAMINOPHEN, AND LIDOCAINE AROUND THE INTERVENTIONAL RADIOLOGY DRAINAGE SITE. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17092469 ↗
• InjuryFeb 17, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WAS SUCCESSFULLY PLACED DURING AN ENDOSCOPIC RETROGRADE (ERCP) CHOLANGIOPANCREATOGRAPHY PROCEDURE IN THE BILE DUCT, PERFORMED ON (B)(6) 2022. ON (B)(6) 2023, DURING A GASTROENTEROLOGY (GI) TELEPHONE CONSULT, THE PATIENT COMMUNICATED FEELING POORLY WITH A LOW GRADE FEVER, NAUSEA, VOMITING AND WEIGHT LOSS. THE PATIENT WAS THEN PRESENTED TO THE HOSPITAL WITH A RISEN 3.1 BILIRUBIN AND ABDOMINAL PAIN. A CT SCAN SHOWED THE PLASTIC STENT WITH PNEUMOBILIA BUT LOW-DENSITY LESION IN THE LEFT HEPATIC LOBE C/F NEW LESION VERSUS ABSCESS. THE ADVANIX BILIARY STENT WAS EXPLANTED FROM THE PATIENT AND A NEW WALLFLEX STENT WAS PLACED IN THE COMMON HEPATIC DUCT. THE PATIENT WAS GIVEN IV ZOSYN AS MEDICATION FOR THE ADVERSE EVENT.

  Patient problems: Abdominal Pain; Fever; Nausea; Vomiting

  MAUDE report 16396449 ↗
• InjuryFeb 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 CORPORATION THAT A ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS FOUND THAT THE GUIDE CATHETER BECAME BROKEN WHEN THE STENT WAS INSERTED INTO THE DELIVERY SYSTEM, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH DIFFERENT BRAND OF 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. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 9,2023, CLARIFYING THAT THE BROKEN GUIDE CATHETER WAS REMOVED FROM THE PATIENT USING A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311582 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A PROCEDURE IN THE COMMON BILE DUCT. THE EXACT EVENT DATE WAS NOT REPORTED. DURING ROUTINE FOLLOW-UP, ON AN UNKNOWN DATE, IT WAS FOUND THAT THE PATIENT HAD A DUODENAL PERFORATION ON THE OPPOSING WALL FROM THE AMPULLA, IT WAS CONFIRMED VIA CT AND ENDOSCOPY. A DRAIN WAS PLACED TO HELP THE PERFORATION TO HEAL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE EXPECTED TO BE FULLY RECOVERED.

  Patient problems: Perforation

  MAUDE report 15065475 ↗
• MalfunctionJul 20, 2022Break; Positioning Failure; Detachment of Device or Device Component; Break; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING A PROCEDURE. THE EVENT DATE WAS NOT REPORTED. DURING THE PROCEDURE, WHEN THE ADVANIX BILIARY STENT WAS ATTEMPTED TO DEPLOY, IT WAS FELT THAT THE GUIDE CATHETER BECAME TENSE AND RELEASE WAS COMPLICATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED AND SHOWED THAT THE GUIDE CATHETER WAS DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15064832 ↗