BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS?

    MDR report key: 23397932 · Received October 27, 2025

    Report

    Report Number
    3005099803-2025-05633
    Event Type
    Injury
    Date Received
    October 27, 2025
    Date of Event
    December 13, 2023
    Report Date
    October 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729904595
    PMA / PMN Number
    K233318
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE LOT NUMBER. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. G2: LITERATURE SOURCE: KAZUYUKI MATSUMOTO, YUKI FUJI, MOTOYUKI OTSUKA. "SUCCESSFUL REMOVAL OF A BURIED LUMEN-APPOSING METAL STENT WITHOUT COMPLICATIONS USING PANCREATIC DRAINAGE AND A HEMOSTATIC AGENT" CLINICAL ENDOSCOPY. 2025; 58:476-477. HTTPS://DOI.ORG/10.5946/CE.2024.233. H6: IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE. IMDRF PATIENT CODE E2338 CAPTURES THE REPORTABLE EVENT OF SWELLING. IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF INFLAMMATION. IMDRF PATIENT CODE E2337 CAPTURES THE REPORTABLE EVENT OF STENOSIS, NON-VASCULAR. IMDRF PATIENT CODE E2314 CAPTURES THE REPORTABLE EVENT OF FISTULA. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC PROCEDURE. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE TITLED "SUCCESSFUL REMOVAL OF A BURIED LUMEN-APPOSING METAL STENT WITHOUT COMPLICATIONS USING PANCREATIC DRAINAGE AND A HEMOSTATIC AGENT" BY KAZUYUKI MATSUMOTO. THE ARTICLE DESCRIBES A CASE OF A 46-YEAR-OLD MAN WITH ALCOHOL-INDUCED CHRONIC PANCREATITIS WHO PRESENTED WITH JAUNDICE ON DECEMBER 13, 2023. COMPUTED TOMOGRAPHY (CT) REVEALED A BILIARY STRICTURE DUE TO COMPRESSION OF THE PANCREATIC HEAD BY A PSEUDOCYST. A HOT AXIOS STENT WAS PLACED VIA THE STOMACH. NINE WEEKS LATER, ACUTE PANCREATITIS DEVELOPED, AND CT REVEALED A BURIED LAMS CAUSED BY INFLAMMATION-INDUCED PANCREATIC HEAD SWELLING, WITH STRICTURE AND DISRUPTION OF THE PANCREATIC DUCT AROUND THE LAMS. IT COULD NOT BE REMOVED AND DUODENAL EDEMATOUS STENOSIS PREVENTED TRANS PAPILLARY PANCREATIC DUCT DRAINAGE. THE PATIENT WAS TRANSFERRED FOR ENDOSCOPIC ULTRASONOGRAPHY-GUIDED DRAINAGE OF THE PANCREATIC DUCT. THE PANCREATIC DUCT WAS PUNCTURED USING A 22-GAUGE NEEDLE, AND PANCREATOGRAPHY REVEALED STRICTURE AND DISRUPTION OF THE DUCT AT THE PANCREATIC HEAD. A PANCREATIC STENT WAS PLACED THROUGH THE STRICTURE AFTER FISTULA DILATION, AND SIMULTANEOUS LAMS REMOVAL WAS ATTEMPTED USING A DIRECT-VIEWING ENDOSCOPE. THE LAMS WAS EMBEDDED IN GRANULATION TISSUE. BY GRASPING THE INNER PORTION OF THE LAMS WITH FORCEPS AND APPLYING FIRM TRACTION USING THE ENDOSCOPE, THE LAMS WAS SUCCESSFULLY REMOVED. AFTER LAMS REMOVAL, OOZING WAS CONFIRMED IN THE FISTULA LUMEN AND HEMOSTASIS WAS ACHIEVED BY APPLYING A HEMOSTATIC AGENT. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352921 AXIOS? UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553650 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R