BEUDAMED
    FDA Adverse Event Other Summary report: N

    CRYOVALVE

    MDR report key: 499377 · Received December 5, 2003

    Report

    Report Number
    1063481-2003-00090
    Event Type
    Other
    Date Received
    December 5, 2003
    Date of Event
    November 5, 2003
    Report Date
    November 5, 2003
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003, PATIENT WITH PREVIOUS HOMOGRAFT AORTIC ROOT REPLACEMENT AND HISTORY OF CONGENITAL DEFECTS REPAIRED AS A CHILD UNDERWENT EXPLANT OF THE AORTIC VALVE & CONDUIT ALLOGRAFT DESCRIBED IN SECTION D SECONDARY TO LEFT VENTRICLE TO LEFT ATRIUM FISTULA, FALSE ANEURYSM OF THE ASCENDING AORTA AND AORTIC INSUFFICIENCY AND MITRAL INSUFFICIENCY. DURING THE PROCEDURE, THE SURGEON NOTED A LARGE (6-8 MM) PERFORATION IN THE GREATER CURVATURE PORTION OF THE OLD HOMOGRAFT DESCENDING AORTA AND FOUND NUMEROUS SMALLER 2-3 MM PERFORATIONS IN IT. ACCORDING TO THE OPERATIVE NOTES, THE PATIENT TOLERATED THE PROCEDURE, REMAINED STABLE AND WAS TRANSFERRED TO THE CARDIOVASCULAR INTENSIVE CARE UNIT IN GOOD CONDITION. FURTHER INFORMATION INCLUDED ON THE TRANSESOPHAGEAL ECHOCARDIOGRAM INDICATES THAT THE PATIENT DID WELL AFTER THE INITIAL SURGERY (IMPLANT OF THE HOMOGRAFT IN 2002) BUT EXPERIENCED AN INFECTION AND ENDOCARDITIS RESULTING IN PERFORATION OF THE HOMOGRAFT RESULTING IN PERFORATIONS OF THE ANTERIOR LEAFLET OF THE MITRAL VALVE AND PERFORATIONS OF THE HOMOGRAFT RESULTING IN A PSEUDOANEURYSM SURROUNDING THE ROOT OF THE AORTA. NO FURTHER INFORMATION ON THE PATIENT'S CURRENT CONDITION HAS BEEN PROVIDED TO THE MANUFACTURER TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| O| R