BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 5124181 · Received September 29, 2015

    Report

    Report Number
    MW5056770
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 18, 2015
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    LWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MECHANICAL AORTIC VALVE 21 MM 21AGFN-756 SN (B)(4) WAS SEATED AT 1030. WHILE SEATING IT, ONE OF THE CARBON LEAFLETS BROKE OFF. ENDOSCOPIC EQUIPMENT WAS OPENED TO CHECK FOR POSSIBLE VALVE DEBRIS. HEART WAS FLUSHED MULTIPLE TIMES; HOWEVER, DEBRIS MAY HAVE BEEN RETAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642333 ST JUDE MEDICAL MECHANICAL HEART VALVE SJM REGENT LWQ ST JUDE MEDICAL 21AGFN-76

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening| O| R