BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MECHANICAL HEART VALVE

    MDR report key: 2256929 · Received September 16, 2011

    Report

    Report Number
    2648612-2011-00065
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    September 16, 2011
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT DOUBLE VALVE REPLACEMENT SURGERY DUE TO SEVERE CALCIFICATION. INTRAOPERATIVELY, THE ANNULUS WAS SIZED WITH AN SJM SIZER. A 21 MM SJM VALVE WAS IMPLANTED IN THE AORTIC POSITION AND A 27 MM SJM VALVE WAS IMPLANTED IN THE MITRAL POSITION. AFTER RE-WARMING THE PATIENT AND REMOVING THE CROSS CLAMP, THE LV STARTED DISTENDING. THE PATIENT'S CHEST WAS RE-OPENED AND ONE OF THE AORTIC VALVE LEAFLETS WAS FOUND TO BE STUCK IN THE OPEN POSITION. THE VALVE WAS REMOVED AND REPLACED WITH A SMALLER 19 MM SJM VALVE. THE PATIENT WAS DISCHARGED 8 DAYS POSTOPERATIVELY. DURING A ONE-MONTH FOLLOW-UP, THE PATIENT'S PROSTHETIC HEART VALVES (PHV'S) WERE FUNCTIONING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MECHANICAL HEART VALVE STANDARD HEART VALVE LWQ ST. JUDE MEDICAL, PUERTO RICO, INC. (CS) 21A-101

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R