BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2160614 · Received July 6, 2011

    Report

    Report Number
    2953200-2011-01241
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ARTERIAL OCCLUSION. MILD TORTUOSITY, MILD CALCIFICATION IN THE COMMON ILIACS; AORTIC NECK ANGULATION OF AN UNKNOWN DEGREE AND RECENT 40 MM RECENT GROWTH (>5%) IN THE ANEURYSM. INFRARENAL BIFURCATED STENT GRAFT HAD BEEN DEPLOYED TOO HIGH AND THE RENAL ARTERIES WERE COVERED. CONCLUSION: MILD TORTUOSITY, MILD CALCIFICATION IN THE COMMON ILIACS; AORTIC NECK ANGULATION OF AN UNKNOWN DEGREE AND RECENT 40 MM RECENT GROWTH (>5%) IN THE ANEURYSM. INFRARENAL BIFURCATED STENT GRAFT HAD BEEN DEPLOYED TOO HIGH AND THE RENAL ARTERIES WERE COVERED.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ONE MONTH AGO. THE COMMON ILIAC VESSELS HAD MILD TORTUOSITY AND MILD CALCIFICATION; THERE WAS AN AORTIC NECK ANGULATION OF AN UNKNOWN DEGREE. IT WAS REPORTED THAT THE PHYSICIAN DECIDED TO PERFORM THIS IMPLANT DUE TO A RECENT 40 MM GROWTH (>5 %) IN THE ANEURYSM. THE INFRARENAL BIFURCATED STENT GRAFT HAD BEEN DEPLOYED TOO HIGH AND THE RENAL ARTERIES WERE COVERED. A SURGICAL CONVERSION WAS NECESSARY. USER ERROR AND INACCURATE DELIVERY OF THE DEVICE CONTRIBUTED TO THE SITUATION. UPON INITIAL INSPECTION, THERE HAD BEEN NO ISSUES WITH THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00873429

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention