BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT

    MDR report key: 1594701 · Received February 3, 2010

    Report

    Report Number
    2242352-2010-00219
    Event Type
    Death
    Date Received
    February 3, 2010
    Date of Event
    August 24, 2009
    Report Date
    January 4, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEING INVESTIGATED. THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AS REQUIRED. ALL MFG AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH APPLICABLE QUALITY PROCEDURES. THE PRODUCTION BATCH RECORD FOR THIS PRODUCT SHOWS THAT IT WAS RELEASED IN ACCORDANCE WITH ALL GOVERNING QA/QC PROCEDURES PRIOR TO DISTRIBUTION. (B) (4).

    Description of Event or Problem · 1

    AS REPORTED ON A VOLUNTARY MEDWATCH REPORT: ON (B) (6) 2009, PT UNDERWENT REPLACEMENT OF AORTIC ROOT WITH 27 (B) (4) FREE-STYLE BIOPROSTHESIS AND REPLACEMENT OF ASCENDING AORTA WITH PROXIMAL ARCH RECONSTRUCTION UTILIZING HYPOTHERMIC CIRCULATORY ARREST EMPLOYING A NO. 28 HEMASHIELD GRAFT AND BYPASS OF THE DISTAL RIGHT CORONARY ARTERY. PT WAS ADMITTED ON (B) (6) 2009 WITH FEVER, TACHYCARDIA AND ATRIAL FLUTTER AND EXPIRED ON (B) (6) 2009. CAUSE OF DEATH (PER AUTOPSY) WAS INVOLVEMENT OF PROSTHETIC AORTIC VALVE, AORTIC VALVE VEGETATIONS WITH INVOLVEMENT OF ASPEGILLUS AD MICROEMBOLI WITH ASPERGILLUS IN CORONARY ARTERY. ADDENDUM: MFR OF HEART VALVE (B) (4). IT WAS REPORTED THAT THE AUTOPSY REPORT WILL NOT BE AVAILABLE TO THE MFR DUE TO (B) (4) LAW. ADD'L INFO RECEIVED ON 01/05/2010: THIS EVENT WAS ALSO REPORTED TO (B) (4) BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT SEALED VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC 175428P 12228220

    Patients

    Seq Age Sex Outcome Treatment
    1 Death