BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE

    MDR report key: 1132629 · Received August 22, 2008

    Report

    Report Number
    2648612-2008-00028
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    June 13, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THE SURGEON INITIALLY ATTEMPTED TO IMPLANT A LARGER 19MM SJM MECHANICAL HEART VALVE, BUT AFTER IT WAS SEATED, IT WAS NOTED THAT THE ORIFICE OF THE RIGHT AND LEFT CORONARY ARTERIES WERE MARKEDLY STRETCHED AND OCCLUDED. THE VALVE WAS REMOVED AND RATHER THAN PERFORM AN AORTIC ENLARGEMENT PROCEDURE BECAUSE THE PT HAD BEEN ON CARDIOPULMONARY BYPASS FOR QUITE SOME TIME, THE ABOVE-REFERENCED 17MM VALVE WAS SELECTED. AFTER THE VALVE WAS SEATED IN THE ANNULUS, A LEAFLET WAS OBSERVED TO BE FRACTURED. THE VALVE AND LEAFLET FRAGMENTS WERE REMOVED AND IT WAS REPLACED WITH ANOTHER SJM 17MM MECHANICAL VALVE. THE PT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL, RECOVERED AND WAS DISCHARGED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL, PUERTO RICO, INC. (CS) 17AHPJ-505

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention