BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAILOR ANNULOPLASTY RING

    MDR report key: 2050896 · Received April 1, 2011

    Report

    Report Number
    2648612-2011-00030
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD MILD MITRAL REGURGITATION AFTER SURGERY THAT PROGRESSED AND SURGERY WAS REQUIRED. THERE WAS A FISSURE BETWEEN A2 AND P2. THE LEAFLET WAS EXTRACTED AND THE RING WAS REMOVED AND REPLACED WITH A TISSUE VALVE FROM ANOTHER MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAILOR ANNULOPLASTY RING TAILOR ANNULOPLASTY RING KRH ST. JUDE MEDICAL PUERTO RICO, INC. (CS) TARP-33

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R