BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 1908981 · Received November 22, 2010

    Report

    Report Number
    MW5018319
    Event Type
    Death
    Date Received
    November 22, 2010
    Date of Event
    May 18, 2010
    Report Date
    November 12, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH HYPOTENSION. FOUND TO HAVE DISTAL STENT MIGRATION AND RUPTURED ABDOMINAL AORTIC ANEURYSM. REQUIRED CONVERSION TO AORTA ILIAC UNIGRAFT AND FEMORAL-FEMORAL CROSSOVER. PT DISCHARGED WITHOUT ENDOLEAK BUT EXPIRED IN NURSING HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX ADVANTAGE STENT GRAFT MIH MEDTRONIC 812532
    2 MEDTRONIC ANEURX ADVANTAGE STENT GRAFT MIH MEDTRONIC B13855
    3 MEDTRONIC ANEURX ADVANTAGE STENT GRAFT MIH MEDTRONIC B07239
    4 MEDTRONIC ANEURX ADVANTAGE STENT GRAFT MIH MEDTRONIC A71202

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| R