BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TEX

    MDR report key: 38288 · Received September 10, 1996

    Report

    Report Number
    2025240-1996-00002
    Event Type
    Injury
    Date Received
    September 10, 1996
    Date of Event
    July 25, 1996
    Report Date
    September 9, 1996
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MCI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE USER FACILITY REPORTS THAT THE INFO WAS PROVIDED TO GORE ON 7/31/1996, WE HAVE NO RECORD OF THAT OCCURRENCE. PT'S OPERATIVE NOTES WERE ATTACHED TO USER REPORT AND ARE INCLUDED WITH THIS FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    43-YEAR-OLD MALE ADMITTED ON 7/21/1996 WITH SEVERE LIFE-THREATENING HYPERKALEMIA WITH CONGESTIVE HEART FAILURE. PT IS ON CHRONIC HEMODIALYSIS AND RECENTLY HAD A SHUNT REPLACED WHICH WAS AN UPPER ARM LOOP CONFIGURATION WITH RECURRENT REACCUMULATION OF FLUID IN THE AXILLA. PT UNDERWENT AN EVACUATION AND DEBRIDEMENT OF LEFT AXILLARY FLUID MASS AND REPLACEMENT OF SHUNT USING 8 MM RING. PTFE8 CM IN LENGTH INTERPOSITION GRAFT ON 7/31/1996. THE GRAFT WAS NOTICED TO BE WEEPING FLUID THROUGH THE INTERSTICES OF THE GRAFT. THE PT WAS DISCHARGED HOME ON 8/3/1996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TEX Implant EPTFE VASCULAR PROSTHESIS MCI W.L. GORE & ASSOCIATES, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention