BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 9133597 · Received September 30, 2019

    Report

    Report Number
    2135147-2019-00317
    Event Type
    Injury
    Date Received
    September 30, 2019
    Date of Event
    September 3, 2019
    Report Date
    October 24, 2019
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010052
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF DEFORMITY UPON DEPLOYMENT COULD NOT BE CONFIRMED. THE INVESTIGATION CONFIRMED THE DEVICE MET FUNCTIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT UNDER NON-PHYSIOLOGICAL CONDITIONS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF COMMERCIALIZATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REPORT NUMBER: 2135147-2019-00285. ON (B)(6) 2019, A 8 MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. WHILE DEPLOYING, THE LA DISK DEFORMED INTO COBRA. THE DEVICE WAS REPLACED WITH A 10 MM OCCLUDER (LOT 6060699), BUT THAT DEVICE ALSO DEPLOYED IN A COBRA FORMATION. THERE WAS NO REPLACEMENT DEVICE AVAILABLE SO THE DEVICE WAS CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    928734 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-008 6833887 00811806010052

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other