BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE SYMMETRY AORTIC CONNECTOR

    MDR report key: 501720 · Received December 2, 2003

    Report

    Report Number
    MW1030452
    Event Type
    Injury
    Date Received
    December 2, 2003
    Date of Event
    February 20, 2001
    Report Date
    December 2, 2003
    Manufacturer
    ST. JUDE
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ST. JUDE AORTIC SYMMETRY DEVICE WAS USED TO SEW THREE VEIN GRAFTS. ONE GRAFT IS NOW 90% BLOCKED AND REQUIRES INTERVENTION. THE OTHER TWO ARE 30% BLOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE SYMMETRY AORTIC CONNECTOR ST. JUDE FZP ST. JUDE * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening