BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2202066 · Received August 5, 2011

    Report

    Report Number
    2953200-2011-01399
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: (ENDOLEAK, GRAFT MIGRATION). RESULTS/CONCLUSIONS: (SHORT, DILATED, AND ANGULATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 28 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT APPROXIMATELY 1 MONTH AGO, THE PATIENT WAS BEING EVALUATED FOR ANOTHER MEDICAL CONDITION, WHEN AN INCIDENTAL FINDING OF THE STENT GRAFT MIGRATION WAS NOTED. THE STENT GRAFT WAS ALL THE WAY IN THE ANEURYSM SAC, AND THERE WAS A LARGE PROXIMAL TYPE I ENDOLEAK. AT THE TIME OF MIGRATION, THE ANEURYSM MEASURED 11.8 CM IN DIAMETER, AND THE AORTIC NECK WAS 1 CM LONG WITH AN ANGULATION OF 60-70 DEGREES. THE MIGRATION WAS ATTRIBUTED TO THE SHORT, DILATED, AND ANGULATED AORTIC NECK. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING AN ENDURANT CUFF PROXIMALLY, WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK AND MIGRATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE. AN INTERNAL REVIEW OF POST-IMPLANT FILMS SHOW THAT THE STENT GRAFT HAS MIGRATED DOWN TO THE ANEURYSM SAC WITH A PROXIMAL TYPE I ENDOLEAK. THE AORTA DIAMETER BELOW THE RENALS IS 25 MM X 36MM. THERE IS GOOD BILATERAL DISTAL LIMB FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00075885

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention