BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 1001019 · Received February 20, 2008

    Report

    Report Number
    2017233-2008-00077
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 24, 2008
    Report Date
    February 19, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PHYSICIAN IMPLANTED A 25MM HELEX SEPTAL OCCLUDER IN 2007 TO CLOSE A 9-10MM ANEURYSMAL ASD (ATRIAL SEPTAL DEFECT). AT THE 3 AND 6 MONTH FOLLOW UP, THE DEVICE LOOKED TO BE IN POSITION; HOWEVER, ON A TTE (TRANSTHORACIC ECHOCARDIOGRAPHY) ON APPROX EIGHT MONTHS LATER, THE PHYSICIAN SUSPECTED THAT THE DEVICE HAD CHANGED POSITION AND THAT A RESIDUAL LEAK WAS PRESENT. ON 2008, THE PHYSICIAN AND A GORE CLINICAL SPECIALIST REVIEWED THE IMAGES AND IT WAS REPORTED THAT THE IMAGES FROM THAT DAY AND THE IMPLANT IMAGES APPEAR TO SHOW AN UNEQUAL DEPLOYMENT WITH MORE OF THE DEVICE ON THE RIGHT SIDE OF THE SEPTUM. THE PHYSICIAN WAS ABLE TO CROSS THE SEPTUM AND BALLOON SIZE THE SHUNT AT 5MM. A 25MM AMPLATZER PFO OCCLUDER WAS IMPLANTED SO THAT THE LEFT DISC COVERED THE HELEX LEFT DISC AND THE RIGHT DISC WAS POSITIONED IN BETWEEN THE SEPTUM AND THE RIGHT DISC OF THE HELEX DEVICE. NO RESIDUAL SHUNT WAS NOTED AT THE CONCLUSION OF THE PROCEDURE. THE PT WAS DOING WELL FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HELEX SEPTAL OCCLUDER SEPTAL OCCLUDER MLV W.L. GORE & ASSOCIATES, INC WLG216 04799831

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention