BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES VALVE EXPANDED CUFF

    MDR report key: 1002511 · Received February 26, 2008

    Report

    Report Number
    2648612-2008-00010
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, WHEN THE VALVE WAS REMOVED FROM THE PATIENT, ONE OF THE LEAFLETS WAS ALREADY FOUND TO BE DISLODGED. THE OTHER LEAFLET WAS BROKEN BY A MEMBER OF THE SURGICAL TEAM AFTER THE VALVE WAS EXPLANTED. ACCORDING TO THE SURGEON, THE DISLODGED LEAFLET REMAINED IN THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MASTERS SERIES VALVE EXPANDED CUFF ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL, PUERTO RICO, INC. 21AECJ-502

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other