Advanix™ Pancreatic Stent M00536590Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729857532), received between Apr 15, 2019 and Dec 6, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 18, 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.

• MalfunctionDec 6, 2021Difficult or Delayed Positioning; Material Deformation; Difficult or Delayed Positioning; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PANCREATIC STENT PLACEMENT PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTICED THAT THE STENT WAS KINKED ON THE GUIDE CATHETER. AS THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STYLET WAS DIFFICULT TO WITHDRAW AND CAUSED THE PUSH CATHETER CATHETER TO KINK. AFTER LOCKING AND DRIVING THE DELIVERY CATHETER FORWARD, THE STENT WAS ABLE TO RELEASE FROM THE GUIDE CATHETER AND THE ADVANIX PANCREATIC STENT WAS DEPLOYED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12936559 ↗
• MalfunctionApr 15, 2019Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC STENTING PROCEDURE PERFORMED IN THE PANCREATIC DUCT ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WITHDRAWING THE GUIDE CATHETER. WHEN APPLYING EXTRA FORCE TO RETRACT THE CATHETER AND DEPLOY THE STENT, THE GUIDE CATHETER LIFTED AND THE STENT BECAME FLATTENED. WHILE ATTEMPTING TO REMOVE THE DEVICE FROM THE SCOPE, THE GUIDE CATHETER RETRACTED AND DEPLOYED THE STENT, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8514817 ↗