BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 189444 · Received September 25, 1998

    Report

    Report Number
    1063481-1998-00020
    Event Type
    Injury
    Date Received
    September 25, 1998
    Date of Event
    March 14, 1995
    Report Date
    September 1, 1998
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TEN Y/O FEMALE MEDICAL HISTORY OF AORTIC STENOSIS SUBVALVULAR AORTIC FIBROMUSCULAR TUNNEL, S/P COARCTATION AND VENTRICULAR SEPTAL DEFECT REPAIR, AND AORTIC SUBVALVULAR MEMBRANE RESECTION, UNDERWENT AN AORTIC ROOT REPLACEMENT WITH ANNULUS ENLARGEMENT PROCEDURE USING A 22MM AORTIC HOMOGRAFT ON 8/19/1992. ON 3/14/95, THE PT REQUIRED RE-OP DUE TO DEHISCENCE OF THE LEFT VENTRICLE TO HOMOGRAFT ANASTOMOSIS WHICH RESULTED IN PSEUDO-ANEURYSM.

    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 12 YR Hospitalization| L| R