BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 721667 · Received June 1, 2006

    Report

    Report Number
    2648612-2006-00011
    Event Type
    Injury
    Date Received
    June 1, 2006
    Date of Event
    February 7, 2006
    Report Date
    May 31, 2006
    Manufacturer
    ST. JUDE MEDICAL, PUERTO RICO, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION INDICATED THE THROMBUS FORMATION AT BOTH PIVOT GUARD AREAS SEVERLY LIMITED MOVEMENT OF BOTH LEAFLETS AND RESULTED IN STENOSIS AND INCOMPETENCE. THERE WAS NOT EVIDENCE FOUND TO SUGGEST THE THROMBUS WAS DUE TO AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY THE REVIEW OF THE VALVE'S MANFACTURING TRAVELER AND THE ANALYSIS PERFORMED. THE CAUSE OF THE THROMBUS FORMATION REMAINS UNK.

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUE TO THROMBUS IMPEDING LEAFLET MOTION RESULTING IN REGURGITATION. IT WAS REPORTED THE PT WAS COMPLAINT WITH WARFARIN AND INR WAS WITHIN THERAPEUTIC RANGE (UNDER 3.0).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM MASTERS SERIES MECHANICAL HEART VALVE ROTATABLE HEART VALVE LWQ ST. JUDE MEDICAL, PUERTO RICO, INC. 25AJ-501 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R