BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER

    MDR report key: 1030099 · Received April 21, 2008

    Report

    Report Number
    2135147-2008-00031
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 31, 2008
    Report Date
    April 21, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER SEPTAL OCCLUDER WAS RECEIVED AT AGA MEDICAL IN ITS ORIGINAL CONFIGURATION AND DECONTAMINATED. THE DEVICE WAS THEN MEASURED AND THE SIZE WAS CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. DESPITE ATTEMPTS TO RECEIVE THE IMAGING OF THIS CASE, NO IMAGING HAS BEEN RECEIVED TO CONFIRM SIZING AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE. THE RESULTS OF OUR INVESTIGATION ARE INCONCLUSIVE DUE TO THE LACK OF INFORMATION RECEIVED FROM THE FIELD. SHOULD THE IMAGING BECOME AVAILABLE AT A LATER DATE, WE WILL FORWARD ANY ADDITIONAL OBSERVATIONS.

    Description of Event or Problem · 1

    THE DEVICE EMBOLIZED 18 HOURS POST IMPLANT AND WAS RETRIEVED. AN 18MM ASO WAS THEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-MF-025 M07J18-11

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention