BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4210499 · Received October 29, 2014

    Report

    Report Number
    2953200-2014-02230
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    July 29, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT WAS BEING SEEN IN THE PHYSICIAN¿S OFFICE FOR FOLLOW UP AND COMPLAINED OF SUDDEN SEVERE ONSET OF LEFT LEG PAIN. THE PATIENT WAS TAKEN FOR TESTS AND IT SHOWED THAT THE PATIENT HAD A LEFT COMMON ILIAC OCCLUSION. THE PHYSICIAN STATED THAT THE OCCLUSION WAS WITHIN THE STENT GRAFT. THE OCCLUSION ON THE LEFT WAS IN THE LIMBS ONLY AND DID NOT GO PAST THE BIFURCATION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR A RIGHT TO LEFT ILEO-FEM BYPASS. THE PHYSICIAN STATED THAT THE PATIENT IS DOING WELL POST PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692253 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04210940

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention