BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM REGENT HEART VALVE

    MDR report key: 1991094 · Received February 11, 2011

    Report

    Report Number
    2648612-2011-00014
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 11, 2011
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC. (CS)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT UNDERWENT DOUBLE VALVE REPLACEMENT SURGERY. INTRAOPERATIVELY, AN SJM MITRAL VALVE WAS IMPLANTED ((B)(4)) WITHOUT INCIDENT. THE SURGEON THEN SIZED THE PT'S AORTIC ANNULUS WITH A 21 MM SIZER (SIZER MODEL UNK). THE SURGEON ATTEMPTED TO IMPLANT A 19 MM REGENT VALVE BUT WAS HAVING DIFFICULTY FITTING THE VALVE IN THE AORTIC POSITION AND OPTED TO REMOVE THE VALVE. THE SURGEON THEN COMPARED THE VALVE TO A 19MM SIZER AND THE VALVE APPEARED LARGER THAN THE SIZER. IT WAS REPORTED, BOTH CORONARY OSTIA WERE COMPROMISED WHICH RESULTED IN THE HEART NOT RECEIVING PROPER BLOOD SUPPLY. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM REGENT HEART VALVE REGENT ROTATABLE VALVE LWQ ST. JUDE MEDICAL PUERTO RICO, INC. (CS) 19AGN-751

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R