Advanix™ Pancreatic Stent M00537150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729856627), received between Jun 12, 2024 and Jun 18, 2024 — classified as 2 injuries.

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.

• InjuryJun 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS IMPLANTED IN THE DORSAL DUCT TO TREAT A PANCREATIC DIVISUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT PRESENTED WITH PANCREATITIS AND WAS ADMITTED THROUGH THE EMERGENCY DEPARTMENT (ED). FLUIDS, ANTI-EMETICS, AND PAIN MEDICATION WERE THEN ADMINISTERED TO THE PATIENT. SUBSEQUENTLY, ON (B)(6) 2021, THE STENT WAS REMOVED WITH ALLIGATOR FORCEPS, AND THE PATIENT WAS TRANSFERRED TO THE INPATIENT WARD FOR CONTINUED MANAGEMENT. THE PATIENT WAS DISCHARGED BUT CONTINUED TO REPORT UNRELENTING PAIN UNTIL (B)(6) 2021. THE RELATIONSHIP BETWEEN THE ADVANIX PANCREATIC STENT AND THE PANCREATITIS WAS UNSPECIFIED.

  Patient problems: Pain; Pancreatitis

  MAUDE report 19555708 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, TO BOSTON SCIENTIFIC CORPORATION. THAT AN ADVANIX PANCREATIC PIGTAIL STENT WAS IMPLANTED IN THE PANCREAS TO TREAT A SUSPECTED PANCREATIC FISTULA, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP). PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. ON (B)(6) 2024, THE PATIENT PRESENTED WITH PANCREATITIS. ON (B)(6) 2024, THE PATIENT PRESENTED WITH ALCOHOL INDUCED PANCREATITIS. THE PATIENT WAS THEN REFERRED TO THE EMERGENCY DEPARTMENT WHERE THE PATIENT RECEIVED IV FLUIDS AND WAS TREATED FOR PAIN MANAGEMENT. THE STENT REMAINS IMPLANTED INSIDE THE PATIENT'S BODY.

  Patient problems: Pancreatitis

  MAUDE report 19523651 ↗