BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 19556735 · Received June 18, 2024

    Report

    Report Number
    3005099803-2024-02807
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 1, 2024
    Report Date
    June 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4, H4: THE LITERATURE ARTICLE DID NOT PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: RYO SUGIURA, KAZUMA KISHI, AND MASAKI KUWATANI. "TEMPORARY RESCUE HEMOSTASIS FOR ARTERIAL HEMORRHAGE USING PENTAPOD FORCEPS DURING DIRECT ENDOSCOPIC NECROSECTOMY" DIGESTIVE ENDOSCOPY 2023; 35: 540 DOI: 10.1111/DEN.14550. BLOCK H6: IMDRF PATIENT CODE E1032 CAPTURES THE REPORTABLE EVENT OF VOMITING. IMDRF PATIENT CODE E230101 CAPTURES THE REPORTABLE EVENT OF FEVER. IMDRF PATIENT CODE E2328 CAPTURES THE REPORTABLE EVENT OF BOWEL OBSTRUCTION. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF DIRECT ENDOSCOPIC NECROSECTOMY WAS PERFORMED. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF DEN WAS PERFORMED USING FORCEPS.

    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, "TEMPORARY RESCUE HEMOSTASIS FOR ARTERIAL HEMORRHAGE USING PENTAPOD FORCEPS DURING DIRECT ENDOSCOPIC NECROSECTOMY" BY RYO SUGIURA, ET AL. ACCORDING TO THE STUDY, A CAUTERY-ENHANCED LUMEN-APPOSING METAL STENT (LAMS) WAS USED IN A PATIENT DIAGNOSED WITH SEVERE ACUTE PANCREATITIS. POST-PROCEDURE, THE PATIENT DEVELOPED FEVER AND VOMITING DUE TO REMNANT GASTRIC OBSTRUCTION. DIRECT ENDOSCOPIC NECROSECTOMY (DEN) WAS THEN PERFORMED USING FORCEPS. THE PATIENT CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072099 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553560

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention