BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 2822204 · Received November 7, 2012

    Report

    Report Number
    2135147-2012-00164
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 17, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P040040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED TO SJM FOR ANALYSIS, AS IT REMAINS IMPLANTED. THE CAUSE OF THE REPORTED EMBOLIZATION UNKNOWN. NOT RETURNED TO SJM FOR ANALYSIS.

    Description of Event or Problem · 1

    THE PATIENT WAS A TRAUMA VICTIM IN WHICH THEIR VENTRICULAR SEPTUM WAS PERFORATED. A STERNOTOMY WAS PERFORMED AND A 14MM AMPLATZER MUSCULAR VSD OCCLUDER (MUSCVSD) WAS IMPLANTED. THE MUSCVSD DEVICE EMBOLIZED SHORTLY AFTER BEING PLACED AND IS CURRENTLY WEDGED BELOW THE MITRAL VALVE. DEVICE REMOVAL WAS DETERMINED TO BE TOO RISKY DUE TO THE PATIENT'S UNSTABLE HEMODYNAMICS. A SECOND MUSCVSD DEVICE WAS PLACED AND REMAINED IN STABLE POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER MUSCULAR VSD OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-VSD-MUSC-014 0911066644

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| R