BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX XPEDIENT BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 2000391 · Received February 18, 2011

    Report

    Report Number
    2953200-2011-00441
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    November 11, 2010
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    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 IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 77 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. AT THE TIME OF THE EVENT, THE AAA WAS 6.7 CM IN DIAMETER. THE AORTIC NECK WAS 23 MM LONG, 18.8 MM IN DIAMETER AT THE RENAL ARTERIES AND 26 MM IN DIAMETER 15 MM BELOW, AND ANGULATED 37.7 DEGREES. A RECENT CT SHOWED NO DIFFERENCE IN THE POSITION OF THE BIFURCATED GRAFT FROM A CT TWO YEARS PRIOR. THE PT GRAFT IS APPROXIMATELY 2.5 CM BELOW THE RENAL ARTERIES; HOWEVER, NO MIGRATION IS CONFIRMED, AS THE INITIAL PLACEMENT IS UNK, AND NO TYPE I ENDOLEAK WAS NOTED. THE PHYSICIAN IS TAKING A PREVENTIVE MEASURE, AND THE PT IS SCHEDULED FOR AN ENDURANT AORTIC CUFF PLACEMENT PROXIMAL TO THE BIFURCATED STENT GRAFT AT A LATER DATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX XPEDIENT BIFURCATED STENT GRAFT (FLEXIBLE) MIH MEDTRONIC CARDIOVASCULAR NA 5753

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention