Advanix™ Pancreatic Stent M00536760Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729856962), received between Apr 3, 2018 and May 1, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryMay 1, 2019Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE DUODENUM PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE STENT PLACEMENT PROCEDURE, OUTSIDE THE PATIENT, WHEN THE PHYSICIAN ATTEMPTED TO LOAD THE 3FR. ADVANIX PANCREATIC DUCT STENT OVER THE .025 JAGWIRE, THE STENT WOULD NOT FIT OVER THE GUIDEWIRE. REPORTEDLY, THE STENT WAS UNABLE TO BE REMOVED OVER THE GUIDEWIRE AND SHEARED OFF THE STENT AND IT BROKE IN HALF. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 4FR. ADVANIX PANCREATIC DUCT STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570055 ↗
• MalfunctionApr 3, 2018Kinked; Kinked

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT PIGTAIL WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) AND STENT PLACEMENT PROCEDURE PERFORMED IN THE PANCREATIC DUCT ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN LOADED THE PUSHER ON AND ATTEMPTED TO DEPLOY THE ADVANIX 3F PLASTIC STENT, HOWEVER, IT WAS NOTICED THAT THE STENT COILED UP INTO THE PUSHER. THE PROCEDURE WAS COMPLETED WITH A 4F ADVANIX 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7392957 ↗