BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE PULMONARY VALVE & CONDUIT

    MDR report key: 2013311 · Received March 10, 2011

    Report

    Report Number
    1063481-2011-00026
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    October 14, 2005
    Report Date
    June 24, 2011
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    NINE CLINICAL EXPERIENCE REPORT FORMS WERE RECEIVED AS A RESULT OF ACADEMIC RESEARCH GRANT (B)(4) INDICATING AN EXPLANT OF A PULMONARY VALVE & CONDUIT ALLOGRAFT. ALL WERE IN PEDIATRIC PATIENTS RANGING FROM 0.1 TO 14 YEARS OLD. THE AVERAGE TIME TO EXPLANT WAS 3.4 YEARS WITH INTERVALS RANGING FORM .06 TO 7.9 YEARS. THREE VALVES WERE USED IN ROSS PROCEDURES AND THE REMAINING SIX WERE USED IN RVOT REPAIR OR OTHER RECONSTRUCTIVE PROCEDURES. ALL NINE CASES SHARED COMMON FAILURE MODES INCLUDING VALVE/CONDUIT STENOSIS, VALVE INSUFFICIENCY, CUSP DEGENERATION, AND CALCIFICATION. ALL OF THESE FEATURES ARE CHARACTERISTIC OF STRUCTURAL VALVE DETERIORATION. NONE OF THE EXPLANTED ALLOGRAFTS WERE RETURNED FOR EVALUATION SO NO DIRECT OBSERVATIONS CAN BE MADE. A REVIEW OF PROCESSING RECORDS FOR EACH ALLOGRAFT WAS PERFORMED. THE REVIEW INDICATED THAT ALL OF THE ALLOGRAFTS WERE PROCESSED ACCORDING TO ALL PROCESSING SPECIFICATIONS AT THE TIME OF PROCESSING. STRUCTURAL VALVE DETERIORATION IS A KNOWN POTENTIAL COMPLICATION OF CARDIAC ALLOGRAFT TRANSPLANTATION. PUBLISHED DATA SHOWS FREEDOM FROM SVD RANGES FROM 76-93% AT 10 YEARS FOR THE ROSS PROCEDURE AND 43-72% AT 10 YEARS IN AN RVOT RECONSTRUCTION PROCEDURE. THE REPORTED EVENTS DO REPRESENT EARLIER THAN EXPECTED GRAFT FAILURE DUE TO SVD. HOWEVER, SUCH EVENTS HAVE BEEN REPORTED IN THE LITERATURE. THESE EVENTS MOST LIKELY REPRESENT EARLY, BUT NO UNEXPECTED, STRUCTURAL VALVE DETERIORATION.

    Description of Event or Problem · 1

    THE REPORT HAS BEEN REJECTED DUE TO BEING A CBER REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOVALVE PULMONARY VALVE & CONDUIT PULMONARY VALVE ALLOGRAFT MIE CRYOLIFE, INC. PV00

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other| R