BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 7828575 · Received August 29, 2018

    Report

    Report Number
    2135147-2018-00132
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    April 26, 2018
    Report Date
    August 29, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010175
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF DEFORMITY UPON DEPLOYMENT COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RECEIVED IN THE PRODUCT PERFORMANCE ENGINEERING LAB FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    A 20MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR USE. WHILE THE DEVICE WAS BEING DEPLOYED, THE DISTAL DISC DEPLOYED DEFORMED, COBRA SHAPED. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 20MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6182093). THE SECOND DEVICE WAS IMPLANTED WITHOUT ANY DEFORMATION ISSUES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667138 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-020 6126088 00811806010175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R