BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 3082935 · Received April 23, 2013

    Report

    Report Number
    2017233-2013-00248
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    February 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    W.L. GORE & ASSOCAITES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MALE PT WAS IMPLANTED WITH A GORE PROPATEN VASCULAR GRAFT TWO YEARS AGO (DATE UNK) IN AN ABOVE-KNEE FEM-POP PROCEDURE. ABOUT SIX WEEK AGO (UNSPECIFIED DATE), THE PT PRESENTED WITH A SWOLLEN LEG. PERIGRAFT FLUID ACCUMULATION WAS OBSERVED THE ENTIRE LENGTH OF THE PROPATEN GRAFT. THE FLUID WAS DRAINED. THE DRAINED FLUE WAS TESTED AND WAS NEGATIVE FOR INFECTION. WITHIN TWO WEEKS, THE PT RETURNED WITH THE SAME COMPLAINT. THE ACCUMULATED FLUID WAS DRAINED FORM THE PT'S LEG. THE TEST WAS NEGATIVE FOR INFECTION. THE GRAFT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174517 GORE PROPATEN VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCAITES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention