BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOVALVE

    MDR report key: 179227 · Received July 27, 1998

    Report

    Report Number
    1063481-1998-00008
    Event Type
    Injury
    Date Received
    July 27, 1998
    Date of Event
    June 19, 1998
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MIE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    ON 04/20/1995, A 25 YR OLD MALE UNDERWENT AORTIC VALVE REPLACEMENT AND ATRIAL SEPTAL DEFECT REPAIR FOR ACUTE BACTERIAL ENDOCARDITIS (STAPHYLOCOCCUS AND STEPTOCOCCUS), INVOLVING AORTIC VALVE AND MYOCARDIAL ABSCESS INTO THE RIGHT VENTRICLE, SECONDARY TO INTRAVENOUS DRUG ABUSE. ON 06/19/1998, PT UNDERWENT REOPERATIVE AORTIC VALVE REPLACEMENT DUE TO STENOSIS AND CALCIFICATION OF THE HOMOGRAFT'S LEAFLETS. SURGEON NOTED THAT PT HAD CONTINUED TAKING INTRAVENOUS DRUGS FOLLOWING FIRST SURGERY. DURING EXPLANT, THERE WAS NO EVIDENCE OF VEGETATIONS OR ANEURYSMS. THE HOMOGRAFT WAS NOTED TO BE EXTREMELY THICKENED AND CALCIFIED.

    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 25 YR Life Threatening| R