BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOGRAFT

    MDR report key: 381065 · Received February 27, 2002

    Report

    Report Number
    2183620-2002-00003
    Event Type
    Malfunction
    Date Received
    February 27, 2002
    Date of Event
    January 24, 2002
    Report Date
    January 30, 2002
    Manufacturer
    BIO-VASCULAR, INC.
    Product Code
    LXA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2002, PT UNDERWENT SURGICAL REPAIR OF AN OBSTRUCTED FEMOROANTERIOR ARTERY WITH IMPLANTATION OF BIOGRAFT. SURGEON STATED BIOGRAFT'S MANUFACTURED ANASTAMOSIS SHOWED LESIONS. SURGEON THEN OVERSUTURED THE ANASTOMOSIS AND IMPLANTED THE DEVICE. APPROX TWO HOURS AFTER IMPLANTATION THE PT SHOWED MASSIVE BLEEDING. THE ANASTOMOSIS WAS THEN RESECTED AND DACRON INTERPOSITION WAS MADE. IN THE PROCESS THE PT EXPERIENCED HEMORRHAGIC SHOCK. THE CURRENT STATUS OF THE PT IS DESCRIBED BY THE SURGEON AS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOGRAFT HUMAN UMBILICAL VEIN GRAFT LXA BIO-VASCULAR, INC. 406505 2-0B07-0530

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention