Advanix™ Pancreatic Stent Kit M00537510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729856283), received between Mar 6, 2018 and Jun 25, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Packaging Compromised” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX PANCREATIC STENT KIT WAS IMPLANTED IN THE PANCREATIC DUCT OF A PATIENT DURING A PANCREATIC DUCT STENT PLACEMENT PROCEDURE, PERFORMED ON (B)(6) 2018. NO ISSUES WERE NOTED WITH THE DEVICE DURING THE PLACEMENT PROCEDURE. ON (B)(6) 2018, THE PATIENT COMPLAINED OF PAIN ON THE RIGHT ABDOMEN. ON (B)(6) 2018, COMPUTED TOMOGRAPHY SCAN WAS PERFORMED AND CONFIRMED THAT THE STENT HAD PERFORATED THE INTESTINAL WALL. THE IMAGE WAS EXAMINED AND THE PHYSICIAN FOUND THAT THE PANCREATIC DUCT MIGRATED FROM THE PANCREATIC DUCT TO THE LARGE INTESTINE, AND IT PERFORATED THE LARGE INTESTINE WALL. INFLAMMATORY FINDINGS WERE ALSO OBSERVED FROM THE TEST RESULTS. ON (B)(6) 2018, THE MIGRATED STENT WAS REMOVED USING A SNARE WITH COLONOSCOPE. ENDOSCOPIC CLIPPING PROCEDURE WAS PERFORMED. AN ANTIBIOTIC WAS ADMINISTERED. THE PATIENT WAS THEN UNDER FOLLOW UP OBSERVATION. NO ADDITIONAL PROCEDURES HAVE BEEN PLANNED FOR THIS PATIENT. PER THE PHYSICIAN¿S ASSESSMENT, AFTER THE STENT MIGRATED FROM ILEOCECAL VALVE, IT IS MOST LIKELY THAT PERFORATION OCCURRED BECAUSE THE STENT REMAINED IN A STATE PERPENDICULAR TO THE INTESTINAL WALL FOR LONG TIME. THIS PATIE

  Patient problems: Inflammation; Pain; Perforation

  MAUDE report 7634533 ↗
• MalfunctionMar 8, 2018Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ PANCREATIC STENT WAS TO BE USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS OBSERVED THAT THE PACKAGING OF THE STENT WAS ALREADY DAMAGED AND THE STERILE SEAL WAS COMPROMISED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7323475 ↗
• MalfunctionMar 6, 2018Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ PANCREATIC STENT WAS TO BE USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS OBSERVED THAT THE PACKAGING OF THE STENT WAS ALREADY DAMAGED AND THE STERILE SEAL WAS COMPROMISED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317426 ↗
• MalfunctionMar 6, 2018Device Packaging Compromised; Device Packaging Compromised

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX¿ PANCREATIC STENT WAS TO BE USED FOR AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING, IT WAS OBSERVED THAT THE PACKAGING OF THE STENT WAS ALREADY DAMAGED AND THE STERILE SEAL WAS COMPROMISED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317412 ↗