BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 2042112 · Received March 29, 2011

    Report

    Report Number
    2017233-2011-00155
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE DEVICE MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS IMPLANTED A 25MM GORE HELEX SEPTAL OCCLUDER. THE PT'S ATRIAL SEPTUM WAS NOTED TO HAVE AN ATRIAL SEPTAL DEFECT, A PATENT FORAMEN OVALE, AND TO BE ANEURYSMAL. FOLLOWING THE PROCEDURE AND WHILE THE PT WAS IN RECOVERY, THE DEVICE WAS NOTED TO HAVE EMBOLIZED TO THE LEFT VENTRICLE. A REINTERVENTION WAS PERFORMED AND THE OCCLUDER WAS REMOVED WITHOUT INCIDENT. A 30MM HELEX DEVICE WAS THEN IMPLANTED AND THE PT WAS DOING 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 WLG216 8063862

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention INTERVENTIONAL SIZING BALLOON| HEPARIN| 11FR TERUMO PINNACLE SHEATH