BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE BIOPROSTHETIC HEART VALVE

    MDR report key: 623715 · Received July 29, 2005

    Report

    Report Number
    2025587-2005-00072
    Event Type
    Injury
    Date Received
    July 29, 2005
    Date of Event
    June 30, 2005
    Report Date
    June 30, 2005
    Manufacturer
    MEDTRONIC HEART VALVES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THAT THE VALVE IMPLANTED FOR APPROXIMATELY 5 YEARS WAS REMOVED DUE TO HEART FAILURE AND ACUTE EPISODES OF SHORTNESS OF BREATH. FAIRLY EXTENSIVE CORONARY DISEASE OBSERVED FROM ORIGINAL IMPLANT. EF AT ORIGINAL OPERATION 70%, NOW 40%. ECHO NOTED MODERATE TO SEVERE AORTIC INCOMPETANCE - TOE SHOWED LEFT CORONARY LEAFLET JET. NO GRADIENT. VISUAL INSPECTION AT SURGERY SHOWS TEAR IN LEFT LEAFLET JET (APPROX. 5X7MM) WITH VERY CLEAN EDGES-LOOKED LIKE A TEAR VS. ABRASION. NO INFECTED. NO CALCIUM SEEN IN ANNULUS, LEAFLET OR WALL. NO SUTURE APPARENT AT THE SITE. FREESTYLE LOOKED EXTREMELY WELL HEALED, VERY CLEAN, PRISTINE. THE FREESTYLE LEAFLETS WERE EXCISED FROM THE AORTIC ROOT WALL. THE VALVE WAS REPLACED WITH A MECHANICAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BIOPROSTHETIC HEART VALVE BIOPROSTHETIC HEART VALVE LWR MEDTRONIC HEART VALVES 995 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention