BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA HEART VALVE

    MDR report key: 2850585 · Received November 16, 2012

    Report

    Report Number
    3009024882-2012-00013
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA. (CS)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POSTOPERATIVELY, THE PHYSICIAN REPORTED THE PT HAD SEVERE AORTIC REGURGITATION AND POSITIVE BLOOD CULTURES FOR A STAPHYLOCOCCUS INFECTION. THE VALVE WAS EXPLANTED AND DURING THE EXPLANT PROCEDURE, THE PHYSICIAN NOTED THAT ONE OF THE VALVE CUSPS WAS FOLDED. HE ALSO OBSERVED A STRAND OF TISSUE THAT RAN PERPENDICULAR TO THE NORMAL PATTERN OF CUSPAL TISSUE. THE PT HAD A 21 MM REGENT VALVE IMPLANTED AND IS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFECTA HEART VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL, COSTA RICA LTDA. (CS) TF-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R