BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT

    MDR report key: 1118423 · Received August 15, 2008

    Report

    Report Number
    2017233-2008-00460
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 14, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SALAMEH MK, HOBALLAH JJ. SUCCESSFUL ENDOVASCULAR TREATMENT OF ANEURYSM SAC HYGROMA AFTER OPEN ABDOMINAL AORTIC ANEURYSM REPLACEMENT: A REPORT OF TWO CASES J. VASC SURG 2008: 48: 457-60.

    Description of Event or Problem · 1

    AS REPORTED IN THE MEDICAL LITERATURE, A MAN PRESENTED IN 2000 WITH A RUPTURED JUXTARENAL AAA, WHICH WAS REPAIRED USING A 20- X 10-MM GORE-TEX AORTOBIILIAC GRAFT. IN 2005 HE WAS FOUND TO HAVE A PERIGRAFT FLUID COLLECTION, MEASURING 12 CM IN MAXIMAL DIAMETER, ON A COMPUTED TOMOGRAPHY (CT) SCAN OBTAINED TO EVALUATE NONSPECIFIC BACK PAIN. A CT-GUIDED ASPIRATION WITH CULTURE YIELDED 600 ML OF STERILE SEROUS FLUID. THE SYMPTOMS RECURRED <= 1 MONTH, AND A CT SCAN REVEALED REACCUMULATION OF THE HYGROMA. THE GORE-TEX GRAFT WAS RELINED WITH ANEURX STENT GRAFTS (MEDTRONIC). THE POSTOPERATIVE COURSE WAS UNEVENTFUL. A FOLLOW-UP CT SCAN 2 MONTHS LATER SHOWED DECREASED HYGROMA SIZE WITH A MAXIMAL SAC DIAMETER OF 8.7 CM. THE PATIENT REMAINS ASYMPTOMATIC WITH A STABLE AORTIC SAC 2 YEARS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIFURCATED GORE-TEX STRETCH VASCULAR GRAFT NONE DSY W.L. GORE & ASSOCIATES, INC WLG302

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention