BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROCOL

    MDR report key: 554137 · Received November 9, 2004

    Report

    Report Number
    2031002-2004-00004
    Event Type
    Death
    Date Received
    November 9, 2004
    Date of Event
    September 11, 2004
    Report Date
    November 9, 2004
    Manufacturer
    HANCOCK JAFFE LABORATORIES, INC.
    Product Code
    MDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 10-CM VASCULAR ACCESS GRAFT WAS IMPLANTED TO REPLACE AN ANEURISMAL SECTION OF FEMORAL ARTERY, AN UNAPPROVED INDICATION FOR THE DEVICE. APPROXIMATELY ONE MONTH POST IMPLANT, BLEEDING DEVELOPED IN THE GROIN AREA AND THE PATIENT DELAYED NOTIFYING THEIR PHYSICIAN UNTIL THE FOLLOWING DAY. THE GRAFT WAS REMOVED AND ACTIVE STAPHYLOCOCCUS INFECTION WAS CONFIRMED. THE SOURCE OF THE BLEEDING (GRAFT VS. NATIVE TISSUE WHICH WAS REPORTEDLY IN POOR CONDITION, COULD NOT BE DETERMINED). THE PATIENT DIED OF SEVERE REFRACTORY METABOLIC ACIDOSIS TWO DAYS LATER. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, ALL SHIPPED DEVICES ARE CERTIFIED STERILE FOLLOWING EXPOSURE TO GAMMA RADIATION. INFECTION IS LISTED AS A POTENTIAL ADVERSE EVENT IN THE INSTRUCTIONS FOR USE. THE INSTRUCTIONS ALSO STATE THAT POSTOPERATIVELY, PROPHYLACTIC MEASURE TO PREVENT INFECTION SHOULD BE TAKEN. NO POSTOPERATIVE REGIMEN OF ANTIBIOTICS WAS PRESCRIBED IN THIS CASE. EARLY POSTOPERATIVE INFECTION IS NOT UNUSUAL FOLLOWING ANY VASCULAR PROCEDURE, PARTICULARLY IN THE GROIN AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROCOL BOVINE MESENTERIC VEIN BIOPROSTHEISIS FOR VASCULAR ACCESS MDQ HANCOCK JAFFE LABORATORIES, INC. HJL016-10-N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| H| R NONE KNOWN