BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2130645 · Received June 14, 2011

    Report

    Report Number
    2953200-2011-01136
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 16, 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)(4). EVAL RESULTS: ARTERIAL/VESSEL OCCLUSION; OCCLUSIVE DISEASE. EVAL CONCLUSION: OCCLUSIVE DISEASE.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM ABDOMINAL AORTIC ANEURYSM APPROX THREE MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS AN AORTIC NECK HAD MODERATE ANGULATION, 28 MM IN DIAMETER AT THE RENAL ARTERIES, 31 MM IN DIAMETER ABOVE THE ANEURYSM, AND 29 MM LONG WITHOUT CALCIFICATION OR THROMBUS. THE ILIAC ARTERIES WERE NON-CALCIFIED, MILDLY TORTUOUS, AND 21-26 MM IN DIAMETER ON THE RIGHT AND 16-24 MM IN DIAMETER ON THE LEFT. AN ENDURANT BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED VIA THE LEFT SIDE WITHOUT ISSUES; DURING THE PROCEDURE, AN EXTENSION LIMB WAS PLACED TO EXTEND TO THE LEFT HYPOGASTRIC, WHICH WAS ALREADY OCCLUDED. IT WAS REPORTED THAT AT THE PT'S ONE MONTH F/U, IT WAS NOTED THAT THERE WAS A KINK AND OCCLUSION OF THE LEFT EXTENSION LIMB. THE LIMB HAD OCCLUDED/KINKED AT THE LEFT HYPOGASTRIC. THE PT WAS TREATED WITH A FEMORAL TO FEMORAL BYPASS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. THE RETURNED SINGLE STILL IMAGE POST-IMPLANT, PRIOR TO THE REPORTED OCCLUSION WAS REVIEWED INTERNALLY. THE OCCLUSION MAY BE RELATED TO PT'S PRE-EXISTING OCCLUSION (OCCLUSIVE DISEASE). THE AREA OF OCCLUSION MAY BE NEAR STENT GRAFT OVERLAP; THE DISTAL ILIAC STENT GRAFT DOES NOT APPEAR TO BE FULLY EXPANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00839880

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention