Advanix™ Pancreatic Stent Kit M00537520Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729856290), received between Jan 2, 2018 and Mar 2, 2020 — classified as 1 injury, 1 malfunction.

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

• MalfunctionMar 2, 2020Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN THE COMMON BILE DUCT AND PANCREATIC DUCT, PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, WHEN THE STENT WAS TAKEN OUT FROM THE PACKAGING, THE STENT GOT CAUGHT IN THE PLASTIC BOX, LEADING THE STENT TO BE FLATTENED AND DEFORMED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9775978 ↗
• InjuryJan 2, 2018Adverse 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 KIT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, A FEW HOURS AFTER A PANCREATIC STENT IMPLANTATION, THE PATIENT EXPERIENCED PAIN AND INFLAMMATORY SYNDROME APPEARED. A CT SCAN WAS PERFORMED AND SHOWED A DOUDENAL PERFORATION AT THE TIP OF THE PANCREATIC STENT IN THE RETROPERITONEAL POSITION. ANTIBIOTIC THERAPY HAS BEEN ADMINISTERED. OVESCO ENDOSCOPIC CLIP TYPE WAS USED TO A J3 ABLATION OF THE STENT AND CLOSURE OF THE INCISION. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: Inflammation; Pain; Perforation

  MAUDE report 7158009 ↗