BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT

    MDR report key: 1409174 · Received June 30, 2009

    Report

    Report Number
    2242352-2009-00022
    Event Type
    Death
    Date Received
    June 30, 2009
    Date of Event
    May 30, 2009
    Report Date
    June 1, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BEING INVESTIGATED. NOTE: ITEMS MARKED "NI" ARE NOT ATTAINABLE AT THIS TIME. SHOULD SUCH INFORMATION BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE DEVICE HISTORY RECORDS FOR THE BATCH WERE REVIEWED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH OUR STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION - THERE ARE NO SIMILAR INCIDENTS AGAINST THIS BATCH.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT AFTER PLACING A GRAFT IN THE ASCENDING AORTA IN 2008, THE PATIENT HAD EXPERIENCED SYMPTOMS OF FEVER, SHORTNESS OF BREATH, FATIGUE AND WEIGHT LOSS. THE PATIENT EXPIRED IN 2009. CANDIDA FUNGUS WAS FOUND IN THE GRAFT. A MEDTRONIC GRAFT WAS ALSO IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT VASCULAR GRAFTS DSY MAQUET CARDIOVASCULAR, LLC 175628P 11080064

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death