BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM REGENT HEART VALVE W/FLEX CUFF

    MDR report key: 1061332 · Received June 13, 2008

    Report

    Report Number
    2648612-2008-00018
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT WITH CONGENITAL AORTIC STENOSIS HAD THIS VALVE EXPLANTED DUE TO PANNUS AND THROMBUS IMPEDING ONE OF THE LEAFLETS. REGURGITATION AND A HIGH GRADIENT OF 107 MMHG WAS OBSERVED. THE SURGEON HAD INDICATED THE PT WAS NON-COMPLIANT WITH THE PRESCRIBED ANTICOAGULATION TREATMENT AND DID NOT DESIRE FOLLOW UP OF OUR ANALYSIS. A 25 MM SJM MECHANICAL VALVE (MODEL 25AJ-501) WAS IMPLANTED. FOLLOWING THE PROCEDURE THE PT WAS STABLE, RECOVERING, AND DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM REGENT HEART VALVE W/FLEX CUFF REGENT ROTATABLE VALVE LWQ ST. JUDE MEDICAL, PUERTO RICO, INC. 21AGFN-756

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization| R