Advanix™ Pancreatic Stent M00536460Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729857402), received between Dec 7, 2016 and Dec 7, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2016Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS REMOVED FROM A PATIENT DURING A STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2016 AS PART OF THE (B)(6) CLINICAL STUDY. ON (B)(6) 2016 THE PATIENT UNDERWENT THE STUDY STENT PLACEMENT PROCEDURE. A BILIARY SPHINCTEROTOMY WAS PERFORMED PRIOR TO STENT PLACEMENT AS WELL AS A PANCREATIC SPHINCTEROTOMY. THE PATIENT UNDERWENT BALLOON DILATION AND HAD AN ADDITIONAL PANCREATIC PLASTIC STENT PLACED (NON-STUDY STENT). CONTRAST WAS INJECTED INTO THE PANCREATIC DUCT FROM THE MAIN PANCREATIC DUCT AND SIDE BRANCHES. THE PANCREATIC DUCT WAS DILATED 4MM. THE STENT INDWELL DURATION WAS 4 WEEKS. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE PATIENT¿S ADVANIX PANCREATIC STENT WAS REPORTED TO HAVE EXPERIENCED A PARTIAL PROXIMAL MIGRATION. THE ADVANIX PANCREATIC STENT WAS REMOVED FROM THE PATIENT EARLIER THAN PLANNED USING A GRASPER. A NON-BSC PLASTIC PANCREATIC STENT WAS PLACED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6152756 ↗