BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3800981 · Received May 8, 2014

    Report

    Report Number
    2953200-2014-00949
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. THE PATIENT PRESENTED FOR ROUTINE FOLLOW UP, WHERE IT WAS DISCOVERED THAT THE ANEURX BIFURCATE HAD MIGRATED DISTALLY. THE PATIENT WAS ASYMPTOMATIC. IT WAS REPORTED THAT THE PHYSICIAN PLANNED TO EXPLANT TWO OF THE STENT GRAFTS. THE PHYSICIAN REPORTED THAT THE ANEURX HAD MIGRATED, AND THAT THE ANEURYSM HAD INCREASED TO 10 CM IN DIAMETER. THE MIGRATION ALSO CREATED A TYPE IA AND TYPE IB ENDOLEAK. AN OPEN SECONDARY CONVERSION WAS PLANNED. THE PHYSICIAN DECIDED TO NOT EXPLANT ANY STENT GRAFT, AND INSTEAD ELECTED TO WRAP TEFLON AROUND THE INFRARENAL AORTA AND RIGHT COMMON ILIAC ARTERY, SUTURING IT TO THE VESSEL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277267 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR M02F552029

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention