BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE-TEX

    MDR report key: 1220583 · Received November 4, 2008

    Report

    Report Number
    MW5008840
    Event Type
    Death
    Date Received
    November 4, 2008
    Date of Event
    March 9, 2008
    Report Date
    October 24, 2008
    Manufacturer
    *
    Product Code
    FIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD PLACED IN HIS LEFT ARM, A BRACHIAL CEPHALIC FISTULA IN 2001 FOR THE PURPOSE OF DIALYSIS. THE FISTULA DID WELL UNTIL LATE 2007 WHEN THERE WERE FREQUENT BLEEDING EPISODES POST DIALYSIS. ONE AREA OF THE UPPER ARM APPEARED TO ENLARGE, IN THE FORM OF AN EGG. THERE APPEARED TO BE AN AREA IN WHICH THE SKIN OPENED, AND IN 2008, THE FISTULA BROKE THROUGH AND PT BLED TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE-TEX AV FISTULA - BRACHIAL - CEPHALIC FIQ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death