Advanix™ Biliary M00534680Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729787235), received between Oct 28, 2018 and Aug 23, 2024 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2024Break; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Break; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS IMPOSSIBLE TO PULL THE SUTURE WHEN THE STENT WAS ATTEMPTED TO BE RELEASED. THE STENT WAS EVENTUALLY DEPLOYED AFTER SEVERAL ATTEMPTS. HOWEVER, THE GUIDE CATHETER GOT STUCK INSIDE THE STENT. THE GUIDE CATHETER WAS THEN REMOVED USING RAPTOR 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 20052630 ↗
• MalfunctionJul 24, 2022Contamination; Contamination

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS OPENED TO BE USED FOR AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE TO BE PERFORMED ON (B)(6) 2022. DURING THE PREPARATION, IT WAS NOTED THAT THE PACKAGE WAS DAMAGED AND THE SEAL WAS DESTROYED. THE STENT IS NO LONGER STERILE AND COULD NOT BE USED ANYMORE. THE PROCEDURE WAS SUCCESSFULLY 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 15090661 ↗
• MalfunctionJun 13, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. THE PROCEDURE DATE WAS NOT REPORTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION RESULTS REVEALED THAT THE GUIDE CATHETER WAS DETACHED, THEREFORE THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. SEE INVESTIGATION SUMMARY FOR MORE DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674069 ↗
• InjuryJan 6, 2022Migration; Migration

  IT WAS REPORTED THAT AN ADVANIX BILIARY STENT WAS IMPLANTED IN THE PATIENT ON AN UNKNOWN DATE. DURING TWO ROUTINE FOLLOW UPS IN THE CLINIC AFTER PLASTIC STENT PLACEMENT, IT WAS REPORTED THAT THE PATIENT CAME IN WITH PAIN IN THE MIDDLE OF THE NIGHT AND SHOWED THAT THE STENT HAD MIGRATED INTO THE SIGMOID COLON AND HAD A PERFORATION. THE STENT WAS REMOVED VIA SURGERY. NO NEW STENT WAS IMPLANTED IN PLACE OF THE MIGRATED 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 "EXPECTED TO FULLY RECOVER".

  Patient problems: Perforation

  MAUDE report 13181649 ↗
• MalfunctionNov 1, 2021Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN HEMOSTASIS PROCEDURE IN THE COMMON BILE DUCT ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT STENT WOULD NOT DISENGAGE FROM THE PUSHER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. 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 12727395 ↗
• MalfunctionMay 26, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2021. DURING PREPARATION, WHEN THEY UNPACKED THE STENT, THE STENT WAS FOUND BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11883099 ↗
• MalfunctionFeb 13, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE BILE DUCT, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE STENT, THE GUIDE CATHETER WAS COMPLETELY DETACHED FROM THE DELIVERY SYSTEM. REPORTEDLY, THE BROKEN INNER GUIDE CATHETER REMAINED WITHIN THE PUSH CATHETER, ENABLING THE DELIVERY SYSTEM TO BE REMOVED IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE ORIGINAL 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9706639 ↗
• MalfunctionJul 31, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE PULL WIRE WAS RETRACTED, THE PHYSICIAN HAD DIFFICULTY REMOVING THE GUIDEWIRE FROM THE PATIENT, WHEN ATTEMPTED TO PULL THE GUIDEWIRE WITH FORCE, THE GUIDEWIRE WAS MANAGED TO BE REMOVED FROM THE STENT. HOWEVER, DUE TO THE MANEUVER, THE GUIDEWIRE LOST ITS PTFE COATING IN PROXIMITY OF THE EXIT PORT AND WAS BLOCKED INSIDE THE GUIDE CATHETER. REPORTEDLY, THE SUTURE WAS STUCK AND THE STENT HAD A BREAK IN THE VICINITY OF THE FIN DUE TO THE MANEUVER YET THE ADVANIX BILIARY STENT WAS IMPLANTED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE CONDITION OF THE PATIENT AT THE CONCLUSION OF THE PROCEDURE WAS NOTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8846402 ↗
• MalfunctionOct 28, 2018Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT WHEN THE DEVICE WAS RECEIVED, IT WAS NOTICED THAT THE PACKAGING OF AN ADVANIX BILIARY STENT WAS BROKEN AND THE STERILITY OF THE DEVICE WAS COMPROMISED. THE EXACT DATE OF THIS EVENT WAS NOT REPORTED. THERE WAS NO PATIENT OR PROCEDURE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8011169 ↗