BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THIN WALLED GORE-TEX STRETCH VASCULAR GRAFT

    MDR report key: 1000184 · Received February 19, 2008

    Report

    Report Number
    2017233-2008-00076
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    June 22, 2006
    Report Date
    February 18, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    IN 2005, THIS PATIENT PRESENTED WITH AN ISCHEMIC LOWER LEFT EXTREMITY, WITH AN OCCLUDED LEFT ILIAC ARTERY, AND WITH AN OCCLUDED LEFT LIMB OF A GORE EXCLUDER AAA ENDOPROSTHESIS STATUS POST ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (PLEASE SEE MEDWATCH 2953161-2008-00014). ON THE NEXT DAY, AN 8 MM THIN WALLED GORE-TEX STRETCH VASCULAR GRAFT WAS IMPLANTED IN THE FEMOROFEMORAL BYPASS POSITION FOR THE ISCHEMIC LOWER LEFT EXTREMITY. APPROX 3 MONTHS LATER, THE PATIENT PRESENTED WITH SEPTICEMIA SECONDARY TO A STAPH INFECTION AND SURGICAL SITE INFECTION. THIS WAS TREATED WITH ANTIBIOTICS WHICH RESOLVED THE INFECTION. IN 2006, A PORTION OF THE THIN WALLED GORE-TEX STRETCH VASCULAR GRAFT WAS EXCISED AND ANOTHER GRAFT IMPLANTED (MANUFACTURER UNKNOWN). A COMPUTED TOMOGRAPHY SCAN PERFORMED IN 2008 SHOWED A PATENT FEMOROFEMORAL BYPASS GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THIN WALLED GORE-TEX STRETCH VASCULAR GRAFT EPTFE VASCULAR PROSTHESIS DSY W.L. GORE & ASSOCIATES, INC. WLG408

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention