BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 2894016 · Received December 20, 2012

    Report

    Report Number
    2017233-2012-00859
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS, AN ENGINEERING EVAL AND A HISTOLOGICAL EVAL ARE CURRENTLY IN PROCESS.

    Description of Event or Problem · 1

    A PT WAS BEING IMPLANTED WITH A GORE PROPATEN VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT IN A BLALOCK-TAUSSIG-SHUNT APPLICATION. IT WAS REPORTED TO GORE THAT A FEW MINUTES AFTER IMPLANT THE SHUNT OCCLUDED. AFTER OPENING THE CLAMP ON THE NATIVE VESSEL, THE SHUNT OCCLUDED. THE PT WAS PUT ON EXTRACORPOREAL CIRCULATION. THE PT IS NOW DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PROPATEN VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 3944539PP025A

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Required Intervention