BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MECHANICAL HEART VALVE EXPANDED CUFF

    MDR report key: 1841249 · Received September 10, 2010

    Report

    Report Number
    2648612-2010-00051
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 10, 2010
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, INC (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT PRESENTED TO THE HOSP WITH AN ELEVATED GRADIENT AND THE AORTIC PROSTHESIS WAS EXPLANTED AND REPLACED WITH A TISSUE VALVE. THE SURGEON THOUGHT THERE WAS SOME PANNUS FORMATION AND SENT THE VALVE TO THE HOSPITAL'S PATHOLOGY DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MECHANICAL HEART VALVE EXPANDED CUFF STANDARD HEART VALVE LWQ ST. JUDE MEDICAL, PUERTO RICO, INC (CS) 19AEC-102

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R