BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 7955680 · Received October 11, 2018

    Report

    Report Number
    2135147-2018-00178
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    September 18, 2018
    Report Date
    November 1, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010199
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF A DEVICE DEPLOYMENT DEFORMATION WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED 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

    ON (B)(6) 2018, A 26MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED BUT NOT IMPLANTED DUE TO SIZING. THE DEVICE WAS EXCHANGED FOR A 24MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 6201959). UPON DEPLOYMENT, THE DEVICE DEPLOYED DEFORMED, COBRA-HEAD SHAPED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT AND A SECOND 24MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER UNKNOWN) WAS SUCCESSFULLY IMPLANTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795507 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-024 6201959 00811806010199

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R