Advanix™ Pancreatic Stent Kit M00537390Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729856382), received between Apr 8, 2021 and Jul 22, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2025Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX PANCREATIC STENT WAS IMPLANTED IN THE PANCREATIC DUCT TO PREVENT PANCREATITIS DUE TO SPONTANEOUS DROP DURING AN ENDOSCOPIC PANCREATIC DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2024. DURING A ROUTINE FOLLOW UP CHECK-UP, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND REVEALED THAT THE STENT REMAINED WITHIN THE INTESTINAL TRACT AND APPEARED TO HAVE PENETRATED IT. THE STENT WAS LEFT IN PLACE, AND A GASTROSCOPY WAS SUBSEQUENTLY PERFORMED ON (B)(6) 2025. THE PROCEDURE CONFIRMED THAT THE STUMP OF THE PANCREATIC DUCT STENT HAD ENTERED THE DIVERTICULUM AND WAS SUCCESSFULLY REMOVED WITHOUT ANY SIGNS OF PERFORATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22572173 ↗
• MalfunctionJun 23, 2025Entrapment of Device; Material Deformation; Material Integrity Problem; Entrapment of Device; Material Deformation; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX PANCREATIC STENT WAS TO BE IMPLANTED IN THE PANCREATIC DUCT TO TREAT A SUSPECTED PANCREATIC CANCER DURING AN ENDOSCOPIC PANCREATIC DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE HOLE IN THE ACCESSORY PUSHER WAS TOO SMALL, WHICH PREVENTED THE GUIDEWIRE FROM EXITING AS INTENDED. THERE MAY BE TRACES OF THE EXIT BEING FORCIBLY WIDENED BY THE NURSE WHERE THE PUSHER'S GUIDEWIRE COMES OUT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS COMPLAINT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULT WHICH REVEALED THAT THE STENT WAS KINKED. PLEASE SEE BLOCK H11 FOR THE FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22312571 ↗
• MalfunctionJan 12, 2023Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX RX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE PANCREA DRAINAGE PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, THE STENT DID NOT ROLL UP CAUSING IT TO SLIP. ANOTHER ADVANIX PANCREATIC STENT WAS OPENED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. INVESTIGATION RESULTS REVEALED THE PANCREATIC STENT WAS KINKED; THEREFORE, THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16153434 ↗
• InjuryNov 9, 2021Difficult or Delayed Positioning; Use of Device Problem; Difficult or Delayed Positioning; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE IN THE PANCREATIC DUCT, PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN ADVANCED THE STENT THROUGH THE GUIDEWIRE AND WHEN IT WAS PULLED OUT FIRMLY AND FORCEFULLY, THE GUIDEWIRE MAY HAVE BOUNCE BACK AND PERFORATED AND THE PANCREATIC DUCT STENT WAS ALSO ADVANCED THROUGH THE GUIDE WIRE AND BECAME PERFORATED. A PERFORATION OF THE PANCREATIC DUCT OCCURRED WHILE THE DEVICE WAS IN PLACE. THE PROCEDURE WAS COMPLETED IN AN EMERGENCY SURGERY TO TREAT THE PERFORATION AND A PANCREATICODUODENECTOMY WAS PERFORMED. AFTER THAT PROCEDURE THE PATIENT CONDITION WAS STABLE AND THE PATIENT WAS DISCHARGED.

  Patient problems: Perforation

  MAUDE report 12776824 ↗
• MalfunctionApr 8, 2021Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING A PANCREATIC DUCT STENT PLACEMENT PERFORMED ON (B)(6) 2021. DURING UNPACKING, OUTSIDE THE PATIENT, THE STENT WAS FOUND TO BE BENT. THEREFORE, THE USAGE WAS DISCONTINUED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ADVANIX PANCREATIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636057 ↗