BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4190469 · Received October 21, 2014

    Report

    Report Number
    2953200-2014-02132
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THERE WAS A TYPE IB ENDOLEAK FROM THE RIGHT DISTAL LIMB. THE ENDOLEAK WAS ATTRIBUTED TO VESSEL DILATATION. AN ENDURANT 16/10/156 LIMB WAS IMPLANTED FROM THE RIGHT SIDE AND SUCCESSFULLY RESOLVED THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666936 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00970455

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Required Intervention