BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE-TEX

    MDR report key: 1241363 · Received November 21, 2008

    Report

    Report Number
    2017233-2008-00893
    Event Type
    Death
    Date Received
    November 21, 2008
    Date of Event
    March 9, 2008
    Report Date
    November 20, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    FIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO CONTACT THE FOOD AND DRUG ADMINISTRATION RESULTED IN NO OTHER INFO BEING AVAILABLE, DUE TO THE RPTR BEING UNWILLING TO RELEASE ANY FURTHER INFO.

    Description of Event or Problem · 1

    A LETTER REC'D FROM THE FDA INDICATED: MAUDE EVENT REPORT (FOI) 07-NOV--2008. MEDICAL SPECIALTY CODE, PRODUCT CODE, REPORT NO. THIS OUTPUT CONTAINS THE MEDICAL DEVICE ADVERSE EVENT REPORTS CURRENTLY AVAILABLE TO THE PUBLIC, IN ACCORDANCE WITH THE FREEDOM OF INFORMATION ACT AND THE REQUESTED SEARCH CRITERIA. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MFR, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT. DATE REC'D: 2008. 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 THE PT BLED TO DEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death