BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 1080507 · Received July 22, 2008

    Report

    Report Number
    2017233-2008-00389
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 18, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A HELEX SEPTAL OCCLUDER TO CLOSE AN ASD (ATRIAL SEPTAL DEFECT). THE DEFECT BALLOON SIZED TO 17-18MM AND THE TOTAL SEPTAL LENGTH WAS 36MM. A 35MM DEVICE WAS IMPLANTED. ON FOLLOW-UP THE NEXT DAY THE RIGHT ATRIAL DISK WAS PARALLEL TO TRICUSPID VALVE. THE PHYSICIAN DECIDED TO REMOVE THE DEVICE IN A TRANSCATHETER PROCEDURE THE FOLLOWING DAY. THE DEVICE WAS SNARED OUT BUT IT WAS NOTED THAT CLOT HAD FORMED ON THE DEVICE AND THE LONG SHEATH. A CLOT WAS NOTED IN THE LEFT ATRIUM IN AN INFERIOR POSITION ABOVE THE LEVEL OF THE CORONARY SINUS. THE PT WAS PLACED ON HEPARIN AND ASPIRIN AND THE CLOT WILL BE MONITORED. THE DEVICE WAS DISCARDED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HELEX SEPTAL OCCLUDER NONE MLV W.L. GORE & ASSOCIATES WLG216 05220494

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization