BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 190834 · Received October 7, 1998

    Report

    Report Number
    1063481-1998-00023
    Event Type
    Injury
    Date Received
    October 7, 1998
    Date of Event
    March 6, 1997
    Report Date
    September 8, 1998
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO YEAR OLD FEMALE WITH MEDICAL HISTORY OF ATRIOVENTRICULAR CANAL AND TETROLOGY OF FALLOT STATUS POST PULMONARY VALVE REPLACEMENT WITH HOMOGRAFT UNDERWENT ANOTHER RIGHT VENTRICULAR OUTFLOW TRACT PROCEDURE USING A 15MM PULMONARY HOMOGRAFT AND A MITRAL VALVE REPLACEMENT ON 06/22/1995. ON 03/06/1997, PT HAD VALVE EXPLANTED AND REPLACED WITH AN 18MM PULMONARY HOMOGRAT DUE TO OUTGROWTH. OPERATIVE REPORT NOTES THE HOMOGRAFT WAS STILL PLIABLE. LEAFLETS NOT CALCIFIED, BUT VALVE OBSTRCUTED DUE TO SOMATIC GROWTH. SITE DOES NOT RELATE THE EVENT TO THE HOMOGRAFT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization| L| R