BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 1941759 · Received December 21, 2010

    Report

    Report Number
    2017233-2010-00570
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    December 20, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS WAS BEEN CONDUCTED. 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 IMPLANTED A GORE HELEX SEPTAL OCCLUDER IN (B)(6) OF 2005. IN (B)(6) 2005, ECHOCARDIOGRAPHY CONFIRMED SATISFACTORY POSITION OF THE DEVICE ON THE ATRIAL SEPTUM. ON (B)(6), 2010, THE PT WAS ADMITTED FOR RECURRENT ISCHEMIC EVENTS. THE DEVICE COULD NOT BE LOCATED ON ECHOCARDIOGRAPHY. ON (B)(6) 2010, THE DEVICE WAS DISCOVERED TO HAVE EMBOLIZED TO THE AORTIC BIFURCATION. A REINTERVENTION WAS PERFORMED AND THE SEPTAL DEFECT WAS CLOSED WITH A SECOND OCCLUDER. THE HELEX DEVICE REMAINS IN SITU WITH NO CLINICAL SEQUELAE. NO FURTHER INTERVENTION IS PLANNED AND THE PT IS DOING WELL.

    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 03162795

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other