BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3913231 · Received July 3, 2014

    Report

    Report Number
    2953200-2014-01355
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 A 5.7CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL NECK DIAMETER IS 25MM AND 1CM IN LENGTH. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AND DUE TO THE PATIENT¿S ANATOMY (SHORT AND CONICAL) PROXIMAL NECK THE STENT GRAFT WAS DEPLOYED BELOW THE RENAL ARTERIES. A TYPE IA ENDOLEAK WAS IDENTIFIED AND THE PHYSICIAN DECIDED TO USE A CUFF AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO LEAKS WERE NOTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390005 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04235549

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention