BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX STENT

    MDR report key: 1953591 · Received January 4, 2011

    Report

    Report Number
    MW5018881
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 27, 2010
    Report Date
    January 4, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD PRIOR CT SCAN AND IT WAS NOTED ON THE SCAN THAT THE TRIPLE AAA STENT WAS LEAKING. PT HAD THE STENT PLACED ON (B)(6) 2006. ADMITTED TO (B)(6) ON (B)(6) 2010, AND TAKEN TO THE OPERATING ROOM ON (B)(6) 2010 FOR REMOVAL OF TRIPLE A STENT. SURGEON FELT THAT THERE HAD BEEN SEPARATION OF PROXIMAL STENT RING FROM GRAFT. PT HAD TO HAVE REDO INTRA OPERATIVE ANGIOGRAM, AAA REPAIR WITH HEMOSHIELD VASCULAR GRAFT, BIFURCATED, WITH REMOVAL OF ANEUR RX STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX STENT ANEURX RX STENT MIH MEDTRONIC YRBRHXC2816165 935065

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability