BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2130002 · Received June 10, 2011

    Report

    Report Number
    2953200-2011-01132
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (SENT GRAFT MIGRATION, ENDOLEAK). (DISEASE PROGRESSION; SEVERE VESSEL TORTUOSITY). CONCLUSIONS: (DISEASE PROGRESSION; SEVERE VESSEL TORTUOSITY).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A LESS THAN 5 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE YEARS AGO. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WAS REPORTED THAT THE PROXIMAL NECK DIAMETER WAS 26MM TO 27MM AND THERE WAS THROMBUS IN THE AORTIC NECK. IT WAS REPORTED THAT THE ORIGINAL PLAN FOR THE INDEX PROCEDURE WAS TO IMPLANT A TALENT GRAFT BECAUSE OF THE PROXIMAL NECK DIAMETER; HOWEVER, THE TALENT GRAFT WOULD NOT GO THROUGH THE ILIAC ARTERIES, SO AN ANEURX STENT GRAFT WAS IMPLANTED. A RECENT CT SCAN SHOWED A DISTAL MIGRATION AND A TYPE 1 ENDOLEAK. THE CAUSE OF MIGRATION WAS REPORTED AS DISEASE PROGRESSION AND AORTIC NECK DILATATION AND NOT BEING ABLE TO PLACE A BIGGER GRAFT AT INITIAL IMPLANT SINCE A TALENT GRAFT WOULD NOT GO THROUGH THE ANATOMY. CURRENTLY, THE VESSEL MORPHOLOGY IS THAT THERE IS APPROXIMATELY 7CM FROM THE RENAL ARTERIES TO THE FLOW DIVIDER OF THE GRAFT WITH SEVERE BILATERAL ILIAC TORTUOSITY AS WELL AS CALCIFICATION; THE AORTIC NECK IS REVERSE FUNNEL SHAPED WITH A DIAMETER OF 26-30 MM ; 33 MM DIAMETER AT 15 MM BELOW THE RENAL ARTERIES; THE RIGHT DISTAL ILIAC FIXATION OF 20 MM AND LEFT DISTAL FIXATION OF 30 MM. THE PATIENT WILL BE TREATED WITH PLACEMENT OF ADDITIONAL AORTIC CUFFS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Congenital Anomaly