BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2905673 · Received January 9, 2013

    Report

    Report Number
    2953200-2013-00041
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (STENT GRAFT MIGRATION). (AORTIC NECK DILATATION).

    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 APPROXIMATELY 6.5 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A ROUTINE FOLLOW-UP APPOINTMENT WHEN IT WAS NOTED THAT THE ANEURX STENT GRAFT HAS MIGRATED 2CMS DISTAL TO THE LEFT RENAL ARTERIES WITH NO EVIDENCE OF AN ENDOLEAK. THE PROXIMAL AORTIC NECK CURRENTLY MEASURES 24MM - 26MM OVER A 1.5 CM DISTANCE AND IS HEALTHY. THERE IS NO THROMBUS OR PLAQUE. THE CAUSE OF THE MIGRATION IS AORTIC NECK DILATATION. THE PATIENT WAS TREATED WITH AN ENDURANT AORTIC CUFF AND THE STENT GRAFT MIGRATION WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11103 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA B12570

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention