BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4173314 · Received October 15, 2014

    Report

    Report Number
    2953200-2014-02076
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 9.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IN THE ILIAC LIMB AT THE TIME OF IMPLANT WAS REPORTED AS THE RIGHT ILIAC ARTERY WAS 21 MM IN DIAMETER, CURRENTLY THE RIGHT ILIAC ARTERY IS 35.7 CM IN DIAMETER DUE TO DISEASE PROGRESSION RESULTING IN ILIAC LIMB DILATATION. CURRENTLY, THE ABDOMINAL AORTIC ANEURYSM IS 10 CM IN DIAMETER. THE PATIENT PRESENTED WITH ABDOMINAL PAIN. A RECENT CT REVEALED THAT THE DISTAL RIGHT ILIAC LIMB HAS LOST WALL APPOSITION RESULTING IN A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 16X13X199 AND THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655283 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00946562

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention