BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4233348 · Received November 6, 2014

    Report

    Report Number
    2953200-2014-02343
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: OFF-LABEL (NECK ANGULATION GREATER THAN 60 DEGREE).

    Description of Event or Problem · 1

    A ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 22.5 MM IN DIAMETER AND 15 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 22-25-21 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 16 MM IN DIAMETER. THE RIGHT FEMORAL ARTERY MEASURED 9.3 MM IN DIAMETER AND THE LEFT FEMORAL ARTERY MEASURED 8.4 MM IN DIAMETER. THE NECK ANGLE WAS GREATER THAN 60 DEGREES. IT WAS REPORTED THAT ON THE FINAL ANGIOGRAM A BLUSH WAS OBSERVED JUST BELOW THE LEFT RENAL ARTERY. THE PHYSICIAN BELIEVES IT MAY HAVE BEEN A PROXIMAL TYPE I ENDOLEAK. AN INTERVENTION WAS PERFORMED AND AN ENDURANT CUFF WAS IMPLANTED RESOLVING THE ENDOLEAK. THE PHYSICIAN STATED THAT THE ENDOLEAK MAY HAVE BEEN DUE TO THE PATIENT¿S REVERSE FUNNEL AORTIC NECK AND ANGULATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712899 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V05903849

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention