BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1030103 · Received April 21, 2008

    Report

    Report Number
    2135147-2008-00030
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 21, 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
    SN
    Reporter Occupation
    PHYSICIAN

    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 PATIENT HAD TWO ATRIAL SEPTAL DEFECTS. A3D ECHO PROBE WAS USED AND PLANNED TO USE A (??) DEVICE TO REPAIR BOTH ASDS. AFTER THREE HOURS, THE CASE WAS ABORTED BECAUSE PHYSICIAN WAS UNABLE TO SECURE THE DEVICE IN THE DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-028 M07C20-13

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention