BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2051288 · Received April 6, 2011

    Report

    Report Number
    2953200-2011-00751
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS AND CONCLUSION: (DEPLOYMENT FAILURE, FEM-FEM BYPASS), (MODERATELY CALCIFIED, MODERATE THROMBUS, MODERATELY TORTUOUS VESSELS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM SACCULAR ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 1 MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED MODERATELY CALCIFIED, MODERATE THROMBUS, MODERATELY TORTUOUS VESSELS. THE AORTIC NECK IS 22 MM IN DIAMETER AT THE RENAL ARTERIES AND IS 10 MM IN LENGTH. THE BIFURCATED STENT GRAFT WAS ADVANCED ON THE RIGHT SIDE AND SUCCESSFULLY DEPLOYED, HOWEVER, THE PHYSICIAN WAS UNABLE TO CANNULATE THE CONTRALATERAL GATE (LEFT SIDE) WITH A GUIDEWIRE. SINCE THE CONTRALATERAL GATE WAS UNABLE TO BE CANNULATED THE PHYSICIAN ELECTED TO IMPLANT A TALENT CONVERTER DEVICE AND PERFORM A FEMORAL TO FEMORAL BYPASS. 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 IRELAND NA V00567787

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention