BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE HEART VALVE

    MDR report key: 543629 · Received September 15, 2004

    Report

    Report Number
    1063481-2004-00034
    Event Type
    Other
    Date Received
    September 15, 2004
    Report Date
    August 16, 2004
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2004 THE CRYOPRESERVED PULMONARY VALVE AND CONDUIT DESCRIBED IN THIS REPORT WAS IMPLANTED INTO A PT. THE PT MEDICAL HISTORY HAS NOT BEEN PROVIDED AND THE CONDITION REQUIRING SURGERY IS UNKNOWN. AT APPROX 1-MONTH FOLLOWING SURGERY, THE PT DEVELOPED POSTOPERATIVE ENTEROCOCCUS ENDOCARDITIS. THE PT WAS TREATED WITH 40 DAYS OF A COMBINATION THERAPY OF THE ANTIBIOTICS AMPICILLIN AND GENTAMICIN. IN 03/2004 (SPECIFIC DATE WAS NOT PROVIDED), THE PT UNDERWENT A SUBSEQUENT PROCEDURE FOR PSEUDOANEURYSM OF THE RIGHT VENTRICULAR OUTFLOW TRACT. AT THE TIME OF THE REOPERATION, THE SURGEON IDENTIFIED FREE FLOATING SUTURES AND COMPLETE DEGRADATION OF THE HOMOGRAFT. ACCORDING TO THE REPORT, THE ENTIRE HOMOGRAFT WAS NOT PRESENT, THEREFORE A SECOND HOMOGRAFT WAS IMPLANTED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE HEART VALVE HEART VALVE (ALLOGRAFT) MIE CRYOLIFE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Hospitalization| L| O| R