BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE FREEDOM SOLO STENTLESS HEART VALVE

    MDR report key: 5973991 · Received September 23, 2016

    Report

    Report Number
    3005687633-2016-00016
    Event Type
    Injury
    Date Received
    September 23, 2016
    Date of Event
    August 13, 2016
    Report Date
    August 24, 2016
    Manufacturer
    LIVANOVA CANADA CORP.
    Product Code
    DYE
    PMA / PMN Number
    P130011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER WAS NOTIFIED ON AUGUST 24, 2016 OF THE FOLLOWING: PATIENT WAS PRESENTED AT THE EMERGENCY UNIT WITH MASSIVE ACUTE PULMONARY EDEMA. TEE REVEALED ACUTE INSUFFICIENCY OF THE AORTIC BIOPROSTHESIS SOLO 25MM GRADE 4/4 WITH FLAIL OF THE RIGHT CORONARY CUSP. PATIENT INTUBATED AND ADMITTED FOR EMERGENCY SURGERY. THE VISUAL ASPECT OF THE SOLO VALVE SHOWED TEAR OF THE RCC AT THE COMMISSURE LEVEL BETWEEN RCC AND LCC. NO SIGNS OF CALCIFICATION OR ENDOCARDITIS. VALVE WAS REPLACED WITH MAGNA EASE 25 MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624847 THE FREEDOM SOLO STENTLESS HEART VALVE TISSUE HEART VALVE DYE LIVANOVA CANADA CORP. ICV0903

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention