BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2900531 · Received January 7, 2013

    Report

    Report Number
    2953200-2013-00034
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT GRAFT MIGRATION, ENDOLEAK, ANEURYSM RUPTURE. AORTIC NECK ANGULATION. CONCLUSION: AORTIC NECK ANGULATION.

    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 SEVEN YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. CURRENTLY THE PROXIMAL AORTIC NECK IS SEVERELY ANGULATED WITH A FUSIFORM ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS LOST TO FOLLOW UP AND PRESENTED EMERGENTLY TO THE EMERGENCY ROOM WITH BACK PAIN. A CT SHOWED THAT THE ANEURYSM HAD RUPTURED DUE TO A DISTAL STENT GRAFT MIGRATION WITH A TYPE I ENDOLEAK PRESENT. THE PATIENT WAS TREATED WITH AN ENDURANT AORTIC CUFF 28X28X49, A TALENT CONVERTER AND 2 OCCLUDER STENT GRAFTS FOLLOWED BY A FEM-FEM BYPASS. THE STENT GRAFT MIGRATION AND ENDOLEAK RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7393 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 663617

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention