BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 1153242 · Received September 5, 2008

    Report

    Report Number
    2017233-2008-00574
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 4, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPER WORK 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 WAS MULTIFENESTRATED, ANEURYSMAL AND HAD A DEFICIENT AORTIC RIM. THE NEXT DAY IT WAS NOTED THAT THE SUPERIOR EDGE OF THE LEFT DISC HAD PROLAPSED THROUGH THE DEFECT AND A LARGE SHUNT WAS PRESENT. THE DEVICE WAS REMOVED IN A TRANSCATHETER PROCEDURE AND A COMPETITOR DEVICE WAS IMPLANTED. THE OCCLUDER WAS DISCARDED BUT IMAGES WILL BE AVAILABLE. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HELEX SEPTAL OCCLUDER NONE MLV W.L. GORE & ASSOCIATES WLG216 05636158

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization