BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2050855 · Received April 1, 2011

    Report

    Report Number
    2953200-2011-00729
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 2, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: ARTERIAL OCCLUSION. RESULTS & CONCLUSIONS: SMALL DISTAL AORTA.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 49.4 MM DIAMETER ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2011. VESSEL TORTUOUSITY WAS MODERATE AND THERE WAS LITTLE CALCIFICATION. AT THE TIME OF IMPLANT AN ATRIUM STENT WAS PLACED INTO THE LEFT RENAL IN A "SNORKEL" TECHNIQUE. IT WAS REPORTED THAT A FOLLOW UP CT WAS DONE ON (B)(6) 2011 AND IT LOOKED GOOD, BUT WITH SOME NARROWING IN LEFT LIMB OF THE STENT GRAFT. ON (B)(6) 2011, THE PT CALLED THE PHYSICIAN FROM OUT OF TOWN AND STATED HER FOOT HAD BEEN COLD FOR THE PAST THREE DAYS. THE DOCTOR HAD HER GO TO LOCAL HOSPITAL IN TEXAS. THE LEFT LIMB OF THE GRAFT WAS FOUND TO BE OCCLUDED AND WAS REQUIRED TO BE THROMBECTOMIZED. THE PT'S LEG SEEMED TO BE RECOVERING. THE OCCLUSION WAS LIKELY DUE TO A SMALL DISTAL AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00567708

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention