BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT SYSTEM

    MDR report key: 2010919 · Received March 4, 2011

    Report

    Report Number
    2953200-2011-00597
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: STENT GRAFT MISPLACEMENT, ARTERIAL/VENOUS OCCLUSION. RESULTS/CONCLUSIONS: INADVERTENTLY COVERING THE HYPOGASTRIC ARTERY.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM WAS UNREMARKABLE, AND THE ILIAC ARTERIES MEASURED 11 MM IN DIAMETER BILATERALLY AT THE BIFURCATION. THE DISTANCE FROM THE RENAL ARTERIES TO THE AORTIC BIFURCATION WAS 11 CM. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT WAS INADVERTENTLY PULLED DOWN SLIGHTLY, COVERING THE HYPOGASTRIC ARTERY ON THE LEFT SIDE. A RELIANT BALLOON WAS USED TO PUSH THE IPSILATERAL LIMB PROXIMALLY, SUCCESSFULLY UNCOVERING THE HYPOGASTRIC ARTERY. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT BIFURCATED STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00791127

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention