BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 2893946 · Received December 19, 2012

    Report

    Report Number
    2017233-2012-00844
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS VERIFIED THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. THE DEVICE REMAINS IMPLANTED AND THEREFORE, AN ENGINEERING ANALYSIS CANNOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PHYSICIAN IMPLANTED A GORE HELEX SEPTAL OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT IN A PT WITH MIGRAINE HEADACHES. FIFTEEN MONTHS AFTER DEVICE IMPLANTATION, A 1-2MM RESIDUAL SHUNT WAS NOTED DURING A F/U VISIT. A CRIBRIFORM DEVICE WAS IMPLANTED OVER THE HELEX DEVICE TO CLOSE THE SHUNT. THE PT DID WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HELEX SEPTAL OCCLUDER MLV / OCCLUDER, TRANSCATHETER SEPTAL MLV W.L. GORE & ASSOCIATES 8663438

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other