BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 190839 · Received October 7, 1998

    Report

    Report Number
    1063481-1998-00021
    Event Type
    Injury
    Date Received
    October 7, 1998
    Date of Event
    July 29, 1998
    Report Date
    September 8, 1998
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 13 YEAR OLD MALE WITH MEDICAL HISTORY OF AORTIC INSUFFICIENCY AND PULMONARY INSUFFICIENCY STATUS POST ROSS PROCEDURE 03/1995. STATUS POST AORTIC VALVULOPLASTY 03/1995 FOR BICUSPID VALVE UNDERWENT REPLACEMENT OF PREVIOUS PULMONARY HOMOGRAFT USING A 25MM PULMONARY HOMOGRAFT, AORTIC ANNULA REDUCTION, AND REPLACEMENT OF ASCENDING AORTA ON 04/02/1997. ON 07/29/1998, PT HAD HOMOGRAFT EXPLANTED DUE TO STENOSIS AND REC'D A 27MM REPLACEMENT HOMOGRAFT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Hospitalization| R