BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23523041 · Received November 11, 2025

    Report

    Report Number
    3005099803-2025-05918
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    January 1, 2018
    Report Date
    November 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: NO SPECIFIC EVENT DATE WAS PROVIDED. HOWEVER, IT WAS MENTIONED THAT AXIOS WAS NOT USED UNTIL 2018. THEREFORE, JANUARY 1, 2018, WAS SELECTED AS A PLACEHOLDER FOR DOCUMENTATION PURPOSES. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE COMPLAINT DEVICE UPN AND 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. BLOCK G2: LITERATURE SOURCE: HIDEYUKI SHIOMI, OMOTAKA SAITO, TSUYOSHI HAMADA, RYOTA NAKANO, SHUNSUKE OMOTO, MAMORU TAKENAKA, MASAHIRO TSUJIMAE, ATSUHIRO MASUDA, SHOGO OTA, SHINYA UEMURA, TAKUJI IWASHITA, SHO TAKAHASHI, TOSHIO FUJISAWA, KENTARO SUDA, SABURO MATSUBARA, KENSAKU YOSHIDA, ET AL. "QUADRANT, NECROSIS, AND INFECTION CRITERIA FOR THE RISK STRATIFICATION OF WALLED-OFF NECROSIS: EXTERNAL VALIDATION USING MULTI-INSTITUTIONAL DATA" GASTROINTESTINAL ENDOSCOPY (2025), 10.1016/J.GIE.2024.12.037. BLOCK H6: IMDRF DEVICE CODE A010402 CAPTURES THE REPORTABLE EVENT OF STENT MIGRATION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING THE HOT AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE TITLED "QUADRANT, NECROSIS, AND INFECTION CRITERIA FOR THE RISK STRATIFICATION OF WALLED-OFF NECROSIS: EXTERNAL VALIDATION USING MULTI-INSTITUTIONAL DATA" BY HIDEYUKI SHIOMI ET AL. THIS MULTI-INSTITUTIONAL RETROSPECTIVE COHORT STUDY EVALUATED PATIENTS WHO UNDERWENT ENDOSCOPIC ULTRASOUND-GUIDED PERIPANCREATIC FLUID DRAINAGE (EUS-PFD) FOR THE TREATMENT OF WALLED-OFF NECROSIS (WON) BASED ON QNI LEVELS; A TOTAL OF 212 OF 423 PATIENTS WERE DRAFTED FROM JANUARY 2010 TO NOVEMBER 2020. HOWEVER, AXIOS WAS NOT USED UNTIL 2018. AMONG THE DEVICES USED, LUMEN-APPOSING METAL STENTS (LAMS), SPECIFICALLY THE HOT AXIOS STENT, WERE INCLUDED IN 56 (26.4%) CASES AS PART OF THE TREATMENT STRATEGY. THE ARTICLE DESCRIBED THAT ADVERSE EVENTS OCCURRED FOLLOWING EUS-GUIDED DRAINAGE PROCEDURES, INCLUDING STENT MIGRATION. PLEASE REFER TO THE REFERENCED ARTICLE FOR FULL DETAILS, DATA ANALYSIS, AND LIST OF PARTICIPATING INVESTIGATORS AND INSTITUTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2524293 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown