BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4103007 · Received September 19, 2014

    Report

    Report Number
    2953200-2014-01873
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION: ANGULATION OF THE AORTIC NECK GREATER 60 DEGREE.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7.2 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED THAT THE AORTA AT RENAL ARTERY IS 24 MM IN DIAMETER. THE LENGTH OF PROXIMAL AORTIC NECK IS 19.5 MM, THE AORTIC NECK ANGULATION IS 62.6 DEGREE, THERE IS MODERATE TORTUOSITY, AND MODERATE CALCIFICATION. THE BIFURCATED STENT GRAFT WAS IMPLANTED HOWEVER, THE ANGIOGRAM REVEALED THAT IT WAS IMPLANTED A FEW MM LOWER THAN INTENDED. THE CAUSE OF THE INACCURATE IMPLANTATION OF THE STENT GRAFT IS RELATED TO THE AORTIC NECK ANGULATION. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 32X32X49 AORTIC CUFF AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582503 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04658355

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention