Advanix™ Biliary M00534580Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729787136), received between Jul 2, 2024 and Nov 25, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2024Break; Difficult to Remove; Use of Device Problem; Material Deformation; Break; Difficult to Remove; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED CENTER BEND STENT WAS IMPLANTED IN THE BILE DUCT TO TREAT A STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. POST-STENT PLACEMENT, ON (B)(6) 2024, AN ATTEMPT WAS MADE TO REMOVE THE STENT USING A SNARE AND GRASPING FORCEPS. HOWEVER, THE END OF THE STENT BROKE INTO TWO PIECES AND THE STENT WAS UNABLE TO BE REMOVED. THE BROKEN PORTION BECAME STRETCHED AND STUCK IN THE DUCT. SUBSEQUENTLY, A SECOND STENT WAS PLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: 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. A PHOTO OF THE DEVICE WAS PROVIDED, WHICH SHOWED THE STENT WAS BROKEN AND DAMAGED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD-F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20774077 ↗
• InjuryJul 2, 2024Break; Activation, Positioning or Separation Problem; Material Deformation; Material Split, Cut or Torn; Break; Activation, Positioning or Separation Problem; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY PRELOADED CENTER BEND STENT WAS USED IN THE BILIARY DUCT TO TREAT STENOSIS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS UNABLE TO SEPARATE FROM THE INTRODUCER. SUBSEQUENTLY, THE INTRODUCER BROKE OFF WHEN IT WAS REMOVED AND WAS RETRIEVED. 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 19656249 ↗