BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3973236 · Received August 1, 2014

    Report

    Report Number
    2953200-2014-01503
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS NOT REPORTED; HOWEVER, IT WAS NOTED THAT THE ANEURYSM IS CURRENTLY 9CM IN DIAMETER. APPROXIMATELY TWO WEEKS POST INDEX REPAIR, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED EMERGENTLY DUE TO A TYPE A AND TYPE B DISSECTION. THE FLAP COMPLETELY COLLAPSED THE STENT GRAFTS. THE PHYSICIAN PERFORMED AN INTERVENTION WITH AN AX FEM-FEM PROCEDURE. THE PHYSICIAN ATTRIBUTED THE DISSECTION DUE TO HYPERTENSION BECAUSE THE PATIENT STOP TAKING MEDICATION. THE INTERVENTION WAS COMPLETED SUCCESSFULLY AND THE TYPE A DISSECTION WAS RESOLVED; HOWEVER, THE TYPE B DISSECTION WAS LEFT UNTREATED AND PATIENT WILL CONTINUE TO BE MONITORED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450290 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04245074

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention