BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 3872832 · Received June 13, 2014

    Report

    Report Number
    2017233-2014-00309
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    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

    THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE EXPLANTED DEVICE WAS DISCARDED AT THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN IMPLANTED A 30MM GORE® HELEX® SEPTAL OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT. THE ASD WAS A 13-14MM ANTERIOR SUPERIOR DEFECT WITH A DEFICIENT AORTIC RIM. THE TOTAL SEPTAL LENGTH WAS 32-34MM. THE DEVICE WAS PLACED IN THE DEFECT BUT THE RIGHT DISC FLARED A LITTLE INTO THE RIGHT ATRIUM. THE PHYSICIAN CHOSE TO LEAVE THE DEVICE OVERNIGHT WITH THE HOPE IT WOULD LAY FLATTER WITH TIME. THE NEXT DAY THE PHYSICIAN WAS CONCERNED WITH THE RIGHT DISC OBSTRUCTING INFERIOR VENA CAVA FLOW, SO HE DECIDED TO REMOVE THE OCCLUDER. THE OCCLUDER WAS SNARED OUT OF THE PATIENT IN AN ADDITIONAL INTERVASCULAR PROCEDURE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE. THE DEFECT WILL BE SURGICALLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349946 GORE HELEX SEPTAL OCCLUDER OCCLUDER, TRANSCATHETER SEPTAL MLV W.L. GORE & ASSOCIATES 12314900

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other (B)(6) 2014 - HEPARIN