Advanix™ Pancreatic Stent Kit M00537410Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729856405), received between Apr 16, 2019 and Sep 30, 2024 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (4 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.

• MalfunctionSep 30, 2024Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS IMPLANTED IN THE PANCREATIC DUCT DURING A PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOT POSSIBLE TO CROSS THE GUIDEWIRE THROUGH THE STENT. THE GUIDEWIRE GOT STUCK IN THE MIDDLE OF THE STENT LOOP. ANOTHER ADVANIX PANCREATIC STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED MDR REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS WHICH REVEALED THAT THE STENT LOOP WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334222 ↗
• InjuryNov 3, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AFTER AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WAS PERFORMED, AN ADVANIX RX PANCREATIC STENT WAS USED FOR PANCREATITIS PREVENTION. THE EVENT DATE WAS NOT REPORTED. AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF ABDOMINAL PAIN AND AN EMERGENCY ERP WAS PERFORMED. THE ADVANIX RX PANCREATIC STENT PENETRATED INTO THE PANCREATIC DUCT, AND UP TO THE PANCREATIC PARENCHYMA. THE STENT WAS REMOVED IMMEDIATELY, A NEW STENT WAS PLACED, AND PANCREATIC DUCT DRAINAGE WAS PERFORMED. PORTAL VEIN THROMBOSIS WAS OBSERVED, AND DIRECT ORAL ANTICOAGULANT (DOAC) WAS ADMINISTERED FOR ABOUT A MONTH. THE PATIENT RECOVERED AND WAS DISCHARGED AFTER A MONTH AND A HALF.

  Patient problems: Abdominal Pain; Perforation; Thrombosis/Thrombus

  MAUDE report 15723073 ↗
• MalfunctionApr 17, 2019Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2019. THE ADVANIX PANCREATIC STENT WAS STUCK INSIDE THE SCOPE DURING ATTEMPTED DEPLOYMENT AND THE PROCEDURE WAS CANCELLED. THE SCOPE WAS THEN USED ON TWO ADDITIONAL PATIENTS WITHOUT THE STENT BEING SEEN. THE SCOPE WAS ALLEGEDLY CLEANED BETWEEN EACH PROCEDURE USING THE HOSPITAL'S ROUTINE TWO STEP PROTOCOL. THIS COMPLAINT IS BEING REPORTED TO ADDRESS THE SECOND OF FOUR ERCP PROCEDURE INVOLVING THIS SCOPE. ACCORDING TO THE COMPLAINANT, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2019, WHEN THE PHYSICIAN ATTEMPTED TO LOAD AN ADVANIX BILIARY STENT INTO THE SCOPE, THE PHYSICIAN NOTICED THE PREVIOUSLY STUCK ADVANIX PANCREATIC STENT STILL LODGED INSIDE THE SCOPE'S CHAMBER. THE LODGED PANCREATIC STENT WAS REMOVED OUT FROM THE SCOPE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8523368 ↗
• MalfunctionApr 16, 2019Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2019. THE ADVANIX PANCREATIC STENT WAS STUCK INSIDE THE SCOPE DURING ATTEMPTED DEPLOYMENT AND THE PROCEDURE WAS CANCELLED. THE SCOPE WAS THEN USED ON TWO ADDITIONAL PATIENTS WITHOUT THE STENT BEING SEEN. THE SCOPE WAS ALLEGEDLY CLEANED BETWEEN EACH PROCEDURE USING THE HOSPITAL'S ROUTINE TWO STEP PROTOCOL. THIS COMPLAINT IS BEING REPORTED TO ADDRESS THE FOURTH OF FOUR ERCP PROCEDURES INVOLVING THIS SCOPE. ACCORDING TO THE COMPLAINANT, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2019, WHEN THE PHYSICIAN ATTEMPTED TO LOAD AN ADVANIX BILIARY STENT INTO THE SCOPE, THE PHYSICIAN NOTICED THE PREVIOUSLY STUCK ADVANIX PANCREATIC STENT STILL LODGED INSIDE THE SCOPE'S CHAMBER. THE LODGED PANCREATIC STENT WAS REMOVED OUT FROM THE SCOPE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520096 ↗
• MalfunctionApr 16, 2019Entrapment of Device; Problem with Sterilization; Entrapment of Device; Problem with Sterilization

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2019. THE ADVANIX PANCREATIC STENT WAS STUCK INSIDE THE SCOPE DURING ATTEMPTED DEPLOYMENT AND THE PROCEDURE WAS CANCELLED. THE SCOPE WAS THEN USED ON TWO ADDITIONAL PATIENTS WITHOUT THE STENT BEING SEEN. THE SCOPE WAS ALLEGEDLY CLEANED BETWEEN EACH PROCEDURE USING THE HOSPITAL'S ROUTINE TWO STEP PROTOCOL. THIS COMPLAINT IS BEING REPORTED TO ADDRESS THE THIRD OF FOUR ERCP PROCEDURES INVOLVING THIS SCOPE. ACCORDING TO THE COMPLAINANT, DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE PERFORMED ON (B)(6) 2019, WHEN THE PHYSICIAN ATTEMPTED TO LOAD AN ADVANIX BILIARY STENT INTO THE SCOPE, THE PHYSICIAN NOTICED THE PREVIOUSLY STUCK ADVANIX PANCREATIC STENT STILL LODGED INSIDE THE SCOPE'S CHAMBER. THE LODGED PANCREATIC STENT WAS REMOVED OUT FROM THE SCOPE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8520093 ↗