BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 16008263 · Received December 19, 2022

    Report

    Report Number
    3005099803-2022-07593
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    June 1, 2016
    Report Date
    December 19, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED BETWEEN JUNE 2016 TO DECEMBER 2019. REPORT SOURCE: LITERATURE SOURCE: GEORGIOS T., PARASKEVAS G., MARIA CHIARA P., MARIO T., IOANNIS K., STEFANO FRANCESCO C., ANTONIO F., ISTVAN H., DIMITRIOS K., ET AL. EFFICACY AND SAFETY OF ENDOSCOPIC DRAINAGE OF PERIPANCREATIC FLUID COLLECTIONS: A RETROSPECTIVE MULTICENTER EUROPEAN STUDY. HELLENIC SOCIETY OF GASTROENTEROLOGY; 2022; 35(6): 654-662. (B)(4).

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF THE FOLLOWING EVENT FROM REFERENCED LITERATURE ARTICLE "EFFICACY AND SAFETY OF ENDOSCOPIC DRAINAGE OF PERIPANCREATIC FLUID COLLECTIONS: A RETROSPECTIVE MULTICENTER EUROPEAN STUDY". ACCORDING TO THE LITERATURE, AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS IMPLANTED TO TREAT A SYMPTOMATIC PERIPANCREATIC FLUID COLLECTION (PFCS) DURING AN ENDOSCOPIC ULTRASOUND (EUS)-GUIDED TRANSMURAL DRAINAGE PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, STENT MIGRATION WAS NOTED AND THE AXIOS CAUTERY MALFUNCTIONED. SEVERAL PATIENT ADVERSE EVENTS WERE ALSO REPORTED SUCH AS BLEEDING, WHICH WAS TREATED WITH AN ANGIOGRAPHIC EMBOLIZATION, PERFORATION THAT WAS CLOSED WITH AN ENDOSCOPIC CLIP AND OBSTRUCTION/FEVER. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010732 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention