BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HELEX SEPTAL OCCLUDER

    MDR report key: 1883921 · Received June 3, 2009

    Report

    Report Number
    2017233-2009-00282
    Event Type
    Injury
    Date Received
    June 3, 2009
    Date of Event
    April 21, 2009
    Report Date
    June 2, 2009
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MLV
    PMA / PMN Number
    P050006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE EXPLANTED DEVICE ARRIVED AT OUR HISTOLOGY LAB ON (B)(4) 2009. ADDITIONAL INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, THE PHYSICIAN IMPLANTED A HELEX SEPTAL OCCLUDER TO CLOSE AN ASD (ATRIAL SEPTAL DEFECT). AT A ONE YEAR FOLLOW-UP ON (B)(6) 2009, IT WAS NOTED THAT THE WIRE FRAME HAD FRACTURED AND THE RIGHT DISC WAS MALPOSITIONED AWAY FROM THE SEPTUM. NO RESIDUAL LEAK WAS REPORTED. ON (B)(6) 2009, THE DEVICE WAS REMOVED AND THE ASD WAS CLOSED IN A SURGICAL PROCEDURE. 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 05258440

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other