BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK MEDICAL, INC.

    MDR report key: 2177050 · Received December 7, 2007

    Report

    Report Number
    2177050
    Event Type
    Injury
    Date Received
    December 7, 2007
    Date of Event
    November 29, 2007
    Report Date
    December 5, 2007
    Manufacturer
    COOK MEDICAL, INC.,
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) UNDERWENT ATTEMPTED STENT GRAFT REPAIR OF ABDOMINAL AORTIC ANEURYSM AND LEFT FEMORAL ARTERY ANEURYSM. THE GRAFT DID NOT FULLY DEPLOY AND PATIENT HAD TO HAVE OPEN REPAIR OF ANEURYSM WHICH WAS COMPLICATED BY DEVELOPMENT OF COMPARTMENT SYNDROME IN LLE. HE UNDERWENT FASCIOTOMY AND SUBSEQUENTLY DEVELOPED CARDIAC ARREST REQUIRING RESUSCITATION, VASOPRESSOR SUPPORT AND MULTI-ORGAN FAILURE WITH METABOLIC ACIDOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK MEDICAL, INC. ZENITH FLEXX AAA MAIN BODY GRAFT MIH COOK MEDICAL, INC., 1903167

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention