BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORTEX GRAFT

    MDR report key: 976917 · Received January 4, 2008

    Report

    Report Number
    MW5004902
    Event Type
    Injury
    Date Received
    January 4, 2008
    Date of Event
    March 30, 2007
    Report Date
    January 4, 2008
    Manufacturer
    W.L. GORE AND ASSOCIATES
    Product Code
    DSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD GORE GRAFT IMPLANTED 2007 FOR AXILLO BIFEMORAL BYPASS. PT SUBSEQUENTLY DEVELOPED AN INFECTION WITH THE BACTERIA MYCOBACTERIUM CHELONAE COMPLEX AND REQUIRED REMOVAL OF IMPLANT AND NEW IMPLANTATION. THIS PT WAS RE-ADMITTED TO THE HOSPITAL WITH LEFT FLANK PAIN AND WAS FOUND TO HAVE AN INFECTED GRAFT. PT WAS ADMITTED SEVERAL TIMES FOR THIS INFECTION AND REQUIRED LONG TERM ANTIBIOTIC COVERAGE FOR THIS. ANOTHER PT ALSO HAD A GORE GRAFT IMPLANTED - 4 MONTHS LATER- AND ALSO DEVELOPED AN INFECTION WITH MYCOBACTERIUM ABSCESSUS, THIS PT ALSO REQUIRED REMOVAL OF IMPLANTED GRAFT. DATES OF USE: FIRST 03/2007-10/2007. SECOND 06/2007-10/2007. DIAGNOSIS OR REASON FOR USE: SERVERE PERIPHERAL VASCULAR DISEASE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORTEX GRAFT GRAFT DSY W.L. GORE AND ASSOCIATES SAX01 04467997
    2 GORTEX GRAFT GRAFT DSY W.L. GORE AND ASSOCIATES SAX01 03899329

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| S