BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 9262214 · Received October 31, 2019

    Report

    Report Number
    2135147-2019-00332
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    October 7, 2019
    Report Date
    October 31, 2019
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010175
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF DEVICE DEFORMATION OR MIS-SIZING OF THE DEVICE WAS REPORTED. AS THERE WAS NO DISTINCTION BETWEEN THE DEVICES, IT COULD NOT BE DETERMINED IF THE DEVICE HAD BEEN MIS-SIZED OR HAD DEFORMED UPON DEPLOYMENT. THE INVESTIGATION CONFIRMED THE DEVICE MET VISUAL AND FUNCTIONAL SPECIFICATIONS WHEN ANALYZED AT ABBOTT. 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 INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A 20MM AMPLATZER SEPTAL OCCLUDER (ASO), ANOTHER 20MM ASO (LOT NUMBER: 6972404) AND TWO 19MM ASOS (LOT NUMBERS: 6174724 AND 5969576) WERE ATTEMPTED FOR IMPLANT. TWO OF THE DEVICES WERE MIS-SIZED AND THE OTHER TWO DEPLOYED DEFORMED IN A "COBRA" FORMATION. THERE IS NO DISTINCTION BETWEEN WHICH DEVICES WERE MIS-SIZED AND DEFORMED. A 22MM ASO (LOT NUMBER: 6889460) WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056878 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-020 6846875 00811806010175

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention