BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3800965 · Received May 8, 2014

    Report

    Report Number
    2953200-2014-00945
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM BIFURCATED WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON AN UNKNOWN DATE. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT IS UNKNOWN. CURRENTLY THE VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS DISEASE PROGRESSION WITH AORTIC NECK DILATATION; THE ANGULATION IS 90 TO 100 DEGREES. THE DIAMETER OF THE AORTIC NECK IS 28 MM. IT WAS REPORTED THAT THE PATIENT PRESENTED AT A ROUTINE FOLLOW-UP AND WAS COMPLIANT WITH FOLLOW UP APPOINTMENTS. IT WAS REPORTED THAT A RECENT CT REVEALED THAT THE ANEURX STENT GRAFT HAS MIGRATED DISTALLY 20 MM WITH A TYPE I ENDOLEAK. THE PHYSICIAN IMPLANTED AN ENDURANT AORTIC CUFF 23X23X49, TO THREAT THE PROXIMAL TYPE I ENDOLEAK AND MIGRATION OF THE STENT GRAFT. THE ENDOLEAK WAS NOT COMPLETELY RESOLVED THEREFORE THE PHYSICIAN IMPLANTED A BARE METAL STENT AT THE LEVEL OF THE RENAL ARTERIES, NOT COVERING THE RENAL ARTERIES. THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277754 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04214635

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention