BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BJORK-SHILEY

    MDR report key: 1320973 · Received February 20, 2009

    Report

    Report Number
    6000012-2009-00001
    Event Type
    Injury
    Date Received
    February 20, 2009
    Report Date
    January 30, 2009
    Manufacturer
    SHILEY, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SECTION WAS COMPLETED BY THE MANUFACTURER. NO MEDWATCH REPORT WAS RECEIVED FROM THE USER FACILITY. LITERATURE CITATION: "LONG-TERM EVENT-FREE SURVIVAL WITH AN EMBOLISED PROSTHETIC JOURNAL OF CARDIOTHORACIC SURGERY 2008, 34 DEVBHANDARI, M.; WOO, E.; HOOPER, T.; AUTHORS.

    Description of Event or Problem · 1

    A COPY OF A JOURNAL ARTICLE WAS RECEIVED BY REP WHICH REPORTED A PATIENT UNDERWENT EMERGENCY SURGERY TO REPLACE A BJORK-SHILEY TILTING DISC MITRAL PROSTHESIS THAT FAILED DUE TO THE ESCAPE OF THE DISC-OCCLUDER FROM THE VALVE. ACCORDING TO THE AUTHOR, THE VALVE WAS REPLACED, BUT THE ESCAPED DISC REMAINED LODGED IN THE THORACIC AORTA WITHOUT ANY COMPLICATION FOR 13 YEARS. ULTIMATELY, THE PATIENT DIED OF TERMINAL HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BJORK-SHILEY HEART VALVE LWQ SHILEY, INC. 23BSU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L