BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2850026 · Received October 4, 2012

    Report

    Report Number
    2850026
    Event Type
    Death
    Date Received
    October 4, 2012
    Date of Event
    September 26, 2012
    Report Date
    October 2, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ATTEMPTED ENDOVASCULAR DEPLOYMENT OF BIFURCATED GRAFT. DURING RETRACTION, THE EDGES OF PREVIOUS ILIAC STENT ENGAGED THE NEW ENDOGRAFT, THE REVERSE-TAPERED TOP CAP AND COULD NOT BE RETRACTED. DURING ATTEMPTS TO RETRACT, ILIAC ARTERY AVULSED AND HEMORRHAGE OCCURRED. OPEN AAA REPAIR COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC * *
    2 ZILVER VASCULAR STENT STENT, ILIAC NIO COOK MEDICAL INC G50132 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death NO OTHER THERAPIES