BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 7985336 · Received October 19, 2018

    Report

    Report Number
    2135147-2018-00187
    Event Type
    Injury
    Date Received
    October 19, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 13, 2018
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010182
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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. THERE WAS A SMALL TEAR IN THE DISTAL DISC PATCH, WHICH HAD NO EFFECT ON ITS FUNCTIONAL PERFORMANCE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2018, AN ASD WAS MEASURED TO 18MM AND A 22MM AMPLATZER SEPTAL OCCLUDER WAS SELECTED FOR IMPLANT. AFTER PLACING THE DEVICE IN THE LEFT ATRIUM, THE DEVICE DEPLOYED DEFORMED, COBRA-HEAD SHAPED. THE DEVICE WAS RETRACTED AND RE-SHEATHED FOUR TIMES AND RE-DEPLOYED DEFORMED ON EACH ATTEMPT. THE DEVICE WAS REMOVED FROM THE PATIENT AND ALSO DEPLOYED DEFORMED. A 20MM AMPLATZER SEPTAL OCCLUDER (LOT NUMBER: 5072166) WAS CHOSEN AS REPLACEMENT, AND WAS IMPLANTED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824150 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-022 6203808 00811806010182

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other| R