BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYROLIFE AORTIC VALVE PLUS CONDUIT

    MDR report key: 599078 · Received April 18, 2005

    Report

    Report Number
    599078
    Event Type
    Malfunction
    Date Received
    April 18, 2005
    Date of Event
    April 6, 2005
    Report Date
    April 7, 2005
    Manufacturer
    CRYOLIFE INC.
    Product Code
    MIE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT UNDERWENT REPAIR FOR TRUNCUS ARTERIOSUS WITH PLACEMENT OF THE 1ST AORTIC HOMOGRAFT 12MM X 3.0 PER PACKAGE. APPROX ONE WEEK LATER, PATIENT BROUGHT BACK TO SURGERY. HOMOGRAFT REMOVED AND A 2ND GRAFT WAS PLACED. 1ST HOMOGRAFT SENT TO PATHOLOGY. HOMOGRAFT WAS MISLABELED FOR SIZE. FOLLOW UP REVEALS: THE SPECIMEN OR EXPLANTED HOMOGRAPT CONSISTED OF A CYLINDRICAL CONDUIT WITH A HEART VALVE WITH THREE LEAFLETS TOWARDS ONE POLE. THE SPECIMEN MEASURES 2.7 CM IN LENGTH AND RANGES IN GREATEST DIAMETER FROM 1.5 TO 2 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYROLIFE AORTIC VALVE PLUS CONDUIT HOMOGRAFT MIE CRYOLIFE INC. SIZE 12MM X 3CM PER COMPANY *

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA CARDIAC DRUGS