BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC ANEURX BIFRCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 596454 · Received April 27, 2005

    Report

    Report Number
    2953200-2005-01094
    Event Type
    Death
    Date Received
    April 27, 2005
    Report Date
    March 29, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN UNKNOWN SIZE ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THE PT WAS LOST TO FOLLOW-UP AND EXPIRED DUE TO A RUPTURED ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFRCATED STENT GRAFT (FLEXIBLE) AAA STENT DEVICE MIH MEDTRONIC VASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death