BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (HDM FLEXIBLE) WITH XPEDIENT

    MDR report key: 1822765 · Received August 26, 2010

    Report

    Report Number
    2953200-2010-01632
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION RESULTS: (MIGRATION), (DISEASE PROGRESSION WITH AORTIC NECK DILATATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 72 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. CURRENTLY, THE AORTIC NECK HAS A 25 DEGREE ANGULATION, IS 26 MM IN DIAMETER AND IS 20 MM IN LENGTH. THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATATION. THE ILIAC DISTAL FIXATION IS 50 MM ON THE LEFT AND 45 MM ON THE RIGHT. IT WAS REPORTED THAT A RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED 20 MM, AND THERE ARE NO ENDOLEAK PRESENT. THE PHYSICIAN ELECTED TO IMPLANT A 28 ANEURX AORTIC CUFF, WHICH IS 30 PERCENT OVER SIZING AND THE MIGRATION WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (HDM FLEXIBLE) WITH XPEDIENT MIH MEDTRONIC CARDIOVASCULAR NA 181476

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention