BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1050331 · Received May 27, 2008

    Report

    Report Number
    2135147-2008-00045
    Event Type
    Injury
    Date Received
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO A SLIDESHOW PRESENTATION, AN AMPLATZER SEPTAL OCCLUDER EMBOLIZED 14 HOURS POST IMPLANT INTO THE MITRAL VALVE. THE DEVICE WAS PERCUTANEOUSLY RETREIVED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PHYSICIAN, INCLUDING ANY PATIENT DETAILS OR IMAGING OF THE PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AT A LATER DATE, WE WILL REOPEN THE FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-030 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention