BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROVEL DOUBLE VELOUR VASCULAR GRAFT

    MDR report key: 84819 · Received April 16, 1997

    Report

    Report Number
    2242352-1997-00043
    Event Type
    Injury
    Date Received
    April 16, 1997
    Date of Event
    March 4, 1997
    Report Date
    March 18, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    GRAFT WAS IMPLANTED APPROX TWENTY YRS AGO (1977) FOR A ANEURYSM IN BILATERAL LIMBS CLOSE TO THE GROIN. ON 3/4/97, THE GRAFT WAS EXPLANTED DUE TO AN ANEURYSM IN THE ILIACS OF THE GRAFT. THE DOCTOR CLAIMS THAT THE ILIACS APPEARED TO BE DISINTEGRATED. THE POST OPERATIVE CONDITION OF PT WAS FINE, BUT APPROX TWO OR THREE DAYS AFTER SURGERY, THE PT DEVELOPED ISCHEMIA AND DOCTOR ELECTED TO AMPUTATE THE LEFT LEG BELOW THE KNEE. THE PT'S CONDITION AFTER AMPUTATION IS REPORTED AS "DOING FINE". NOTE: THE DOCTOR STATED THAT THE CAUSE OF ISCHEMIA IS UNKNOWN, BUT HE WANTED TO RULE OUT INFECTION AND, OR PRODUCT DEFECT. NOTE: THE GARFT WAS INITIALLY REPORTED TO CO AS AN UNKNOWN GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVEL DOUBLE VELOUR VASCULAR GRAFT Implant MICROVEL DOUBLE VELOUR GRAFT DSY MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other