BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 89102 · Received April 2, 1997

    Report

    Report Number
    2242352-1997-00039
    Event Type
    Malfunction
    Date Received
    April 2, 1997
    Date of Event
    March 4, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE GRAFT WAS IMPLANTED TO REPAIR AN AORTIC ANEURYSM. WHEN THE CLAMP WAS RELEASED BLOOD LEAKED (QUANTITY UNKNOWN) FROM HOLES IN THE BIFURCATION. THE HOLES WERE REPAIRED WITH SUTURES, AND THE LEAKAGE STOPPED. THE ANASTOMOSIS WAS FINISHED AND THE GRAFT WAS LEFT IN. THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant SEALED VASCULAR GRAFT MAL MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 085189 186316

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other