BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3728032 · Received April 4, 2014

    Report

    Report Number
    2953200-2014-00641
    Event Type
    Injury
    Date Received
    April 4, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 11, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED DURING FOLLOW-UP THE LEFT HYPO WAS FOUND TO HAVE BECOME DISEASED AND MEASURED 25 MM IN DIAMETER; HOWEVER, THERE WAS NO DISTAL TYPE I ENDOLEAK JUST A DISEASED HYPOGASTRIC ARTERY. THE HYPOGASTRIC ARTERY WAS EMBOLIZED AND COVERED WITH A 161093 AND A 161682 ENDURANT STENT GRAFT AND THIS SUCCESSFULLY RESOLVED THE ISSUE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204728 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00331234

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention