BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2091674 · Received April 29, 2011

    Report

    Report Number
    2953200-2011-00921
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (STENT GRAFT MIGRATION, RUPTURE). RESULTS/CONCLUSION: (SHORT AND FUNNEL-SHAPED AORTIC NECK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 26 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNK. IT WAS REPORTED THAT AT THE ONE YEAR FOLLOW-UP A DISTAL MIGRATION OF APPROX ONE CM WAS NOTED BUT LEFT INCORRECT. THE PT PRESENTED EMERGENTLY APPROX ONE MONTH AGO WITH LEG, BACK, AND ABDOMINAL PAIN AND THE BIFURCATED STENT GRAFT WAS FOUND TO BE 20 MM BELOW THE RENAL ARTERIES. THE SYMPTOMS AND THE CT SCAN SEEMED TO SUGGEST A RUPTURED ANEURYSM; HOWEVER, THIS COULD NOT BE CONFIRMED AS THERE WAS NO EXTRAVASATION FROM THE ANEURYSM SAC. THERE WAS NO TYPE I OR OTHER ENDOLEAK EVIDENT. AT THE TIME OF MIGRATION, THE ANEURYSM WAS 5-6 CM IN DIAMETER. THE AORTIC NECK WAS REVERSE FUNNEL-SHAPED VARYING IN DIAMETER FROM 23-24-28 MM OVER A LENGTH OF 10 MM OR LESS WITHOUT ANGULATION. THE NECK WAS QUITE SHORT AT 10 MM OR LESS, WHICH IS THOUGHT TO HAVE CONTRIBUTED TO THE MIGRATION. A 28X28X49 MM ENDURANT PROXIMAL CUFF WAS PLACED TO RESOLVE THE MIGRATION SUCCESSFULLY. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00276107

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention