BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 23138690 · Received September 24, 2025

    Report

    Report Number
    3005099803-2025-04830
    Event Type
    Injury
    Date Received
    September 24, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K233318
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. IMDRF IMPACT CODE F1001 CAPTURES THE REPORTABLE EVENT OF THE CANCELLED PROCEDURE. IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT POSITIONING ISSUE. IMDRF DEVICE CODE A090814 CAPTURES THE REPORTABLE EVENT OF STENT NOT VISIBLE UNDER EUS OR FLUOROSCOPY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS INTENDED TO BE IMPLANTED TRANSDUODENAL TO FACILITATE DRAINAGE DURING AN ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE (EUS-GBD) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE FIRST FLANGE WAS DEPLOYED BUT NOT PROPERLY VISUALIZED ON THE SCREEN. AS A RESULT, IT EXPANDED INTO THE ABDOMINAL CAVITY AND HAD TO BE REMOVED. THE STENT WAS DISCARDED DUE TO CONCERNS ABOUT INFECTION, AND IT WAS DECIDED TO REPEAT THE PROCEDURE AT A LATER TIME AFTER CLIPPING THE TREATMENT SITE. THE PATIENT IS REPORTED TO BE STABLE WITH NO COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431876 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE KNS BOSTON SCIENTIFIC CORPORATION M00553540 0036396986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention