Advanix™ Biliary M00534330Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 08714729787426), received between Dec 8, 2016 and Sep 10, 2026 — classified as 3 deaths, 31 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 58 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722899 ↗
• MalfunctionJun 10, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS IMPLANTED IN THE BILE DUCT TO TREAT A STRICTURE DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE BLACK INTRODUCER GOT BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25461023 ↗
• MalfunctionJun 2, 2026Break; Premature Activation; Difficult to Advance

  NOTE: RELATED ADVANIX BILIARY STENT, AUTOTOME AND HYDRA JAGWIRE COMPLAINTS ARE BEING REPORTED UNDER RECORDS (B)(4) AND (B)(4). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX RX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WERE ATTEMPTED TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUSTOMER EXPERIENCED DIFFICULTY DEPLOYING TWO PLASTIC BILIARY STENTS OVER A HYDRAWIRE. THE GUIDEWIRE COULD NOT BE ADVANCED BEYOND THE STENT/SUTURE/PUSHER ASSEMBLY. THE CUSTOMER RETRACTED THE BLACK GUIDE CATHETER TO REPOSITION IT PRIOR TO ADVANCING IT OVER THE WIRE AND ATTEMPTED DEPLOYMENT MULTIPLE TIMES WITHOUT SUCCESS. FORCE WAS SUBSEQUENTLY APPLIED, RESULTING IN SUTURE BREAKAGE AND STENT MISDEPLOYMENT. THE PROCEDURE WAS ABORTED AND NO STENT WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363995 ↗
• MalfunctionJun 2, 2026Break; Premature Activation; Difficult to Advance

  NOTE: RELATED ADVANIX BILIARY STENT, AUTOTOME AND HYDRA JAGWIRE COMPLAINTS ARE BEING REPORTED UNDER RECORDS (B)(4) AND (B)(4). IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ADVANIX RX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WERE ATTEMPTED TO BE IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE CUSTOMER EXPERIENCED DIFFICULTY DEPLOYING TWO PLASTIC BILIARY STENTS OVER A HYDRAWIRE. THE GUIDEWIRE COULD NOT BE ADVANCED BEYOND THE STENT/SUTURE/PUSHER ASSEMBLY. THE CUSTOMER RETRACTED THE BLACK GUIDE CATHETER TO REPOSITION IT PRIOR TO ADVANCING IT OVER THE WIRE AND ATTEMPTED DEPLOYMENT MULTIPLE TIMES WITHOUT SUCCESS. FORCE WAS SUBSEQUENTLY APPLIED, RESULTING IN SUTURE BREAKAGE AND STENT MISDEPLOYMENT. THE PROCEDURE WAS ABORTED AND NO STENT WAS PLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25363989 ↗
• InjuryMay 28, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, THE GUIDE CATHETER BROKE INTO TWO PIECES. THEY USED FORCEPS TO REMOVE THE BROKEN GUIDE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULTS OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325155 ↗
• MalfunctionMay 21, 2026Break; Entrapment of Device; Use of Device Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED TO TREAT CHOLEDOCHOLITHIASIS DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE PATIENT UNDERWENT A SUCCESSFUL ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH COMPLETE STONE EXTRACTION AND SATISFACTORY DUCTAL CLEARANCE. AT THE CONCLUSION OF THE PROCEDURE, AN ATTEMPT WAS MADE TO PLACE THE ADVANIX BILIARY STENT; HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHEN THE STENT REACHED THE ELEVATOR OF THE SCOPE, WHICH CAUSED THE STENT TO GET STUCK AND COULD NEITHER BE DEPLOYED NOR WITHDRAWN. THE PHYSICIAN ATTEMPTED SEVERAL TROUBLESHOOTING STEPS, INCLUDING ADVANCING AND RETRACTING THE DEVICE AND REMOVING THE GUIDEWIRE FROM THE SCOPE. DESPITE THESE EFFORTS, THE STENT REMAINED STUCK. THE PHYSICIAN THEN REMOVED THE ENTIRE SCOPE FROM THE PATIENT WITH THE STENT STILL TRAPPED INSIDE. AN ALTERNATE ERCP SCOPE WAS INTRODUCED, AND A NEW PLASTIC STENT WAS SUCCESSFULLY DEPLOYED. THE PATIENT EXPERIENCED NO COMPLICATIONS AND FULLY RECOVERED. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED, AND IT SHOWED THAT THE ST

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25248290 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM WAS ATTEMPTED TO BE IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE PULLWIRE WAS NOTICED TO BE BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645803 ↗
• InjuryFeb 10, 2026Break; 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 BILE DUCT TO TREAT BILE DUCT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHILE DEPLOYING THE STENT, THE PHYSICIAN INSTRUCTED THE TECHNICIAN TO DEPLOY IT SLOWLY. AS THE END OF DEPLOYMENT WAS BEING REACHED, A SIGNIFICANT "JERK" WAS FELT. THE GUIDEWIRE REMAINED IN PLACE, PASSING THROUGH THE STENT AND INTO THE BILE DUCT. THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDEWIRE; HOWEVER, THE BLACK INTRODUCER CATHETER, WHICH WAS STILL THREADED THROUGH THE STENT WITH THE SUTURE ATTACHED, COULD NOT BE WITHDRAWN. THE BLACK INTRODUCER CATHETER HAD FRACTURED DURING THE DEPLOYMENT ATTEMPT. THE PHYSICIAN THEN REMOVED THE ENTIRE STENT ALONG WITH THE FRACTURED BLACK INTRODUCER CATHETER THROUGH THE PATIENT'S MOUTH USING RAT-TOOTH FORCEPS. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT'S BILE DUCT DURING THE ATTEMPTED DEPLOYMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306433 ↗
• MalfunctionDec 17, 2025Break; 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 STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT FAILED TO SEPARATE FROM THE DELIVERY SYSTEM. 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 BILE DUCT 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. NOTE: THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF CATHETER GUIDE DETACHED OR SEPARATED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23835600 ↗
• MalfunctionSep 4, 2025Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX BILIARY STENT WAS TO BE IMPLANTED TO TREAT AN UNKNOWN INDICATION IN THE BILE DUCT, WITH THE STENT PROTRUDING FROM THE AMPULLA OF VATER, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE INTRODUCER (BLACK PORTION) OF THE NAVIFLEX DELIVERY SYSTEM SEPARATED AND REMAINED INSIDE THE STENT (WITHIN THE DUCT) AFTER DEPLOYMENT. THE GUIDEWIRE HAD ALREADY BEEN REMOVED AT THE TIME OF THE EVENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY RETRIEVE THE SEPARATED INTRODUCER, AND THE STENT REMAINED IN PLACE AS INTENDED. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. 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 INSTRUCTIONS FOR USE (IFU), "IF THE GUIDEWIRE IS NOT COMPLETELY RETRACTED INTO THE DELIVERY SYSTEM, THE STENT CANNOT BE FULLY DEPLOYED."THE USER DID NOT FOLLOW THE IFU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22974208 ↗
• MalfunctionJun 25, 2025Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX DELIVERY SYSTEM DUODENAL BEND STENT WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS UNABLE TO DEPLOY. THERE WERE NO KNOWN PATIENT COMPLICATIONS DUE TO THIS EVENT. NOTE: NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS. THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT WAS DETACHED. PLEASE SEE BLOCK H11 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331311 ↗
• InjuryJun 18, 2025Use of Device Problem; Difficult to Advance; Positioning Problem; Poor Visibility; Use of Device Problem; Difficult to Advance; Positioning Problem; Poor Visibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANIX STENT WITH NAVIFLEX DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE BILE DUCT TO TREAT CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DOCTOR FACED DIFFICULTY PASSING THE STENT INTO THE DUCT. THE STENT WAS EVENTUALLY DEPLOYED BASED ON THE ENDOSCOPIC MARKER, BUT IT WAS NOT VISUALIZED IN THE BILE DUCT, AND IT WAS NOT ATTACHED TO THE DELIVERY SYSTEM EITHER. THE PHYSICIAN PASSED FORCEPS DOWN THE ENDOSCOPE WORKING CHANNEL, BUT THE STENT WAS NOT EXPELLED. THE STENT WAS NOT FOUND. THE PHYSICIAN BELIEVED THAT THE STENT WAS LOST WITHIN THE DUODENUM AND IS CONFIDENT IT WILL BE EXPELLED NATURALLY. ANOTHER OF THE SAME DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE GUIDEWIRE WAS IN THE PATIENT BILE DUCT 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22284896 ↗
• InjuryDec 27, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED DOUBLE BEND STENT WAS USED IN THE BILIARY DUCT FOR DRAINAGE DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE STENT WAS ATTEMPTED TO BE DEPLOYED, THE GUIDE CATHETER WAS DETACHED FROM THE DELIVERY SYSTEM. SUBSEQUENTLY, THE BROKEN GUIDE CATHETER WAS REMOVED USING BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY PRELOADED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027382 ↗
• InjuryDec 11, 2024Migration; Migration

  Patient problems: Perforation

  MAUDE report 20907049 ↗
• InjuryNov 19, 2024Break; Use of Device Problem; Material Deformation; Break; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX BILIARY PRELOADED DOUBLE BEND WAS USED IN THE COMMON BILE DUCT TO TREAT A CHOLEDOCHOLITHIASIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, UPON DEPLOYING THE STENT, THE GUIDE CATHETER WAS KINKED AND COULD NO LONGER BE WITHDRAWN INTO THE PUSH CATHETER. SUBSEQUENTLY, THE PHYSICIAN PULLED THE DELIVERY SYSTEM AND THE GUIDE CATHETER BROKE. A SNARE WAS THEN USED TO REMOVE THE BROKEN GUIDE CATHETER. THE STENT WAS SUCCESSFULLY PLACED, 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 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 20718033 ↗
• MalfunctionNov 15, 2024Positioning Failure; Positioning Failure

  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 AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE STENT DID NOT DEPLOY. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696479 ↗
• InjuryOct 23, 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 AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED IN THE COMMON BILE DUCT TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE INTERNAL GUIDE CATHETER DETACHED FROM THE DELIVERY SYSTEM. THE DETACHED GUIDE CATHETER WAS REMOVED USING RAT TOOTH FORCEPS, 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 20519067 ↗
• MalfunctionSep 25, 2024Contamination; Device Contaminated During Manufacture or Shipping; Contamination; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX-NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PREPARATION, A LONG DARK HAIR WAS NOTICED INSIDE THE UNOPENED PEEL PACK PACKAGING. IT WAS NOT USED IN FEAR OF COMPROMISED STERILITY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20302436 ↗
• InjurySep 12, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED DOUBLE BEND STENT WAS USED TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS DEPLOYED; HOWEVER, IT WAS NOTICED THAT THE INTRODUCER WAS RELEASED FROM THE CATHETER. SUBSEQUENTLY, THE INTRODUCER WAS RETRIEVED. THE STENT WAS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 20204594 ↗
• MalfunctionAug 1, 2024Break; Positioning Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Positioning Failure; 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 USED IN THE DUODENUM TO TREAT STONES DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE INNER CATHETER BROKE OFF AND THE STENT WAS DAMAGED. THE STENT WAS PULLED OUT USING RESCUE GRASPING FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19888237 ↗
• InjuryJul 15, 2024Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED DOUBLE BEND STENT WAS USED IN THE TRACHEAL BRONCHUS FOR AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE (ERBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHILE DEPLOYING THE STENT, THE GUIDE CATHETER BROKE OFF FROM THE DELIVERY SYSTEM AND THE STENT TOGETHER WITH THE GUIDE CATHETER DEPLOYED INSIDE THE COMMON BILE DUCT. SUBSEQUENTLY, RETRIEVAL LIGATURE FORCEPS WERE USED TO REMOVE THE DETACHED FRAGMENTS. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746742 ↗
• MalfunctionMay 15, 2024Break; 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-NAVIFLEX RX BILIARY STENT WAS TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE GUIDE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323936 ↗
• InjuryApr 17, 2024Break; Premature Activation; Difficult to Advance; Break; Premature Activation; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT AND NAVIFLEX RX DELIVERY SYSTEM WAS TO BE USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE DEVICE WAS NOT ABLE TO BE ADVANCED. WHEN THE DEVICE WAS REMOVED, THE STENT PREMATURELY DEPLOYED, AND THE BLACK CATHETER GUIDE WAS BROKEN. THE CATHETER GUIDE WAS REMOVED USING FORCEPS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANIX-NAVIFLEX DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126324 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT AND SAME PATIENT (MFR REPORT (B)(4). IT WAS REPORTED TO BOSTON SCIENTIFIC THAT TWO ADVANIX BILIARY STENTS WERE SUCCESSFULLY PLACED AS STENT EXCHANGE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2023. FROM (B)(6) 2023, AT AN OUTSIDE HOSPITAL (OSH), THE PATIENT EXPERIENCED ACUTE RIGHT UPPER QUADRANT (RUQ) PAIN, EMESIS (VOMITING), CHILLS AND FEVER OF 100.7 DEGREES, CONCERNING FOR CHOLANGITIS. THE PATIENT WAS HOSPITALIZED AND WAS GIVEN LEVOFLOXACIN, METRONIDAZOLE, FLAGYL, DAPTO, AND TYLENOL AS A TREATMENT FOR CHOLANGITIS, FEVER, AND PAIN; AND WAS ALSO ADMINISTERED WITH INTRAVENOUS LACTATED RINGER'S (LR) SOLUTION FOR HYDRATION. FROM (B)(6) 2023, IT WAS REPORTED THAT THE CHOLANGITIS WAS GROWING AND WAS VANCOMYCIN-RESISTANT ENTEROCOCCI COMPLICATED BY SEPSIS, AND POST ERCP PANCREATITIS WITH HEPATIC ABSCESS DUE TO THE PROCEDURE PERFORMED ON (B)(6) 2023. FROM (B)(6) 2023, THE PATIENT EXPERIENCED ABDOMINAL PAIN IN THE SETTING OF TRANSAMINITIS WITH OBSTRUCTION. THE PATIENT WAS DISCHARGED WITH CEFTRIAXONE AND METRONIDAZOLE AS DISCHARGED MEDICATION.

  Patient problems: Abscess; Cholangitis; Fever; Pain; Sepsis; Vomiting

  MAUDE report 17612899 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Device Stenosis; Adverse Event Without Identified Device or Use Problem; Device Stenosis

  NOTE: THIS REPORT IS ONE OF TWO COMPLAINTS THAT PERTAIN TO THE SAME EVENT AND SAME PATIENT (MFR REPORT #3005099803-2023-04102 AND MFR. REPORT #3005099803-2023-04103). IT WAS REPORTED TO BOSTON SCIENTIFIC THAT TWO ADVANIX BILIARY STENTS WERE SUCCESSFULLY PLACED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT, PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, AT (B)(6) HOSPITAL (OSH), THE PATIENT EXPERIENCED ACUTE RIGHT UPPER QUADRANT (RUQ) PAIN, EMESIS (VOMITING), CHILLS AND FEVER OF 100.7 DEGREE, CONCERNING FOR CHOLANGITIS. THE PATIENT WAS HOSPITALIZED AND WAS GIVEN LEVOFLOXACIN, METRONIDAZOLE, FLAGYL, DAPTO AND TYLENOL AS TREATMENT FOR CHOLANGITIS, FEVER AND PAIN; AND WAS ALSO ADMINISTERED WITH INTRAVENOUS LACTATED RINGER'S (LR) SOLUTION FOR HYDRATION. ON (B)(6) 2023, ANOTHER ERCP PROCEDURE WAS PERFORMED TO REMOVE THE PREVIOUSLY IMPLANTED STENTS (THE SUBJECT OF THIS REPORT AND REPORT #3005099803-2023-04102). ANOTHER TWO ADVANIX BILIARY STENTS WERE IMPLANTED IN THIS PROCEDURE AS STENT EXCHANGE. ON (B)(6) TO (B)(6) 2023, IT WAS REPORTED THAT THE CHOLANGITIS WAS GROWING AND WAS VANCOMYCIN-RESISTANT ENTEROCOCCI COMPLICATED BY SEPSIS, AND POST

  Patient problems: Abscess; Cholangitis; Fever; Pain; Sepsis; Vomiting

  MAUDE report 17463602 ↗