BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4121826 · Received September 26, 2014

    Report

    Report Number
    2953200-2014-01938
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 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 FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT DID NOT PRESENT EMERGENTLY; HOWEVER, THEY WERE COMPLAINING OF BELLY PAIN. THE STENT GRAFT WAS INFECTED AND THE DEVICES WERE EXPLANTED. THE PHYSICIAN DID NOT ATTEMPT TO TREAT THE PATIENT PRIOR TO THE EXPLANT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601685 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00561518

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention