BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3813092 · Received May 15, 2014

    Report

    Report Number
    2953200-2014-00983
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER WITH A HEADACHE WITH A THROMBOSED RENAL ARTERY AND WAS IN HYPERTENSION CRISIS. THE PHYSICIAN STATED THAT EVERYTHING LOOKED FINE AT THE TIME OF THE PROCEDURE. THE PHYSICIAN IS UNSURE OF WHAT WOULD HAVE CAUSED THE RENAL THROMBOSIS. THE PATIENT WAS MANAGED WITH OMT (OPTIMAL MEDICAL THERAPY) AND WAS DISCHARGED IN GOOD HEALTH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290420 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03027960

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention