BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2100706 · Received May 18, 2011

    Report

    Report Number
    2953200-2011-01010
    Event Type
    Injury
    Date Received
    May 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: (CALCIFIED ILIAC ARTERIES), (STENT GRAFT MIGRATION, STENT GRAFT KINKING).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON AN UNK DATE. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT STATES THAT THE ANATOMY WAS VERY ANEURYSMAL AT THE RENALS. THE ILIACS WERE VERY CALCIFIED AND THE PT WAS A HIGH RISK. THE CALCIFIED ILIACS MADE THE CUT DOWN DIFFICULT. THE DEVICE CAUGHT ON CALCIUM ON THE WAY OUT. THERE WAS KINK IN THE GRAFT DUE TO THE HEAVILY CALCIFIED PORTION OF THE AORTIC BIFURCATION. THE STENT GRAFT STRUGGLED COMING OUT BUT EVENTUALLY HE WAS ABLE TO UNSHEATH IT. THE PHYSICIAN DECIDED ON A SHORTER LIMB WHICH WAS DEPLOYED WELL. THE DEVICE HAS REPORTEDLY MIGRATED FROM PREVIOUS ANGIOS DONE LAST YEAR AND IT NOW APPEARS AS IF THE ANCHORING PINS ARE PRESSING INTO THE WALL OF THE RENAL ARTERY. THIS PT NOW HAS WORSENING RENAL ARTERY STENOSIS. THERE ARE NO ENDOLEAKS. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00433591

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR