BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA VALVE

    MDR report key: 2201956 · Received August 5, 2011

    Report

    Report Number
    3007113487-2011-00010
    Event Type
    Injury
    Date Received
    August 5, 2011
    Report Date
    August 5, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED ALONG THE REPLACEMENT OF THE ASCENDING AORTA WITH A GRAFT. AN INTRAOPERATIVE AND POSTOPERATIVE TEE WERE PERFORMED AND REVEALED THE VALVE WAS FINE WITH A LOW GRADIENT. THE PT WAS DISCHARGED AND UNDERWENT REHABILITATION. ONE WEEK AGO, THE PT WAS EMERGENTLY ADMITTED TO THE HOSP AND AN ECHO REVEALED AORTIC INSUFFICIENCY. THE PHYSICIAN STATED THERE WAS NO ENDOCARDITIS AND BELIEVES A LEAFLET IS TORN. THE PT WAS GIVEN MEDICATION AND WAS RELEASED. THE PHYSICIAN WILL F/U WITH THE PT IN COUPLE OF WEEKS. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFECTA VALVE NONE LWR ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) TF-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention