BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 2912144 · Received January 11, 2013

    Report

    Report Number
    2953200-2013-00073
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: VESSEL OCCLUSION, INACCURATE STENT GRAFT DELIVERY. POOR QUALITY IMAGING. CONCLUSION: POOR QUALITY IMAGING.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 54 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 17.6 MM IN DIAMETER AND 10 MM IN LENGTH AND MODERATE ANGULATION. THE ILIAC ARTERIES WERE MILDLY CALCIFIED BILATERALLY. AN ENDURANT BIFURCATED STENT GRAFT ETBF2313C166E AND AN ENDURANT ILIAC STENT GRAFT ETLW1616C124E WERE SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT BOTH HYPOGASTRIC ARTERIES WERE COVERED INADVERTENTLY. THE PHYSICIAN MEASURED THE LEFT HYPOGASTRIC ARTERY AND HAD ADEQUATE DISTANCE FOR THE LIMB TO BE IMPLANTED AND USUALLY IMPLANTS THE STENT GRAFT SHORTER THAN EXPECTED. THE HYPOGASTRIC ARTERY WAS COVERED BY 5 MM. THE PHYSICIAN THINKS THE PATIENT WILL BE FINE BECAUSE THE VESSELS ARE GOOD NON-CALCIFIED AND SHOULD COLLATERALIZE FROM THE PROFUNDA. THE PATIENT WAS DISCHARGED AND IS DOING FINE. IT WAS ALSO NOTED THAT THE EVENT WAS DUE TO THE POOR IMAGING QUALITY. THE PATIENT'S ARTERIES WERE SO COMPLIANT THAT WHEN THE STENT GRAFT WAS PUSHED UP TO LAND A LITTLE HIGHER, THE ILIAC ARTERIES SCRUNCHED UP TOO AND DID NOT ALLOW THE STENT GRAFT TO LAND HIGHER AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18068 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03010936

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR