BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4243931 · Received November 11, 2014

    Report

    Report Number
    2953200-2014-02382
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.2 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY AT THE TIME OF THE INDEX PROCEDURE WAS REPORTED AS THE PATIENT HAD SEVERE TORTUOSITY IN THE LEFT COMMON ILIAC, PER THE PRE-IMPLANT STUDY. THE PHYSICIAN ELECTED TO IMPLANT THE STENT GRAFTS TO TREAT THE PATIENT EVEN THOUGH THE VESSELS WERE SEVERELY TORTUOUS. THE PATIENT PRESENTED FOR A ROUTINE VISIT WITH SOME COMPLAINT OF PAIN IN THE LEFT LEG. THE CT SHOWED THAT THE ENTIRE LEFT LIMB HAS FILLED WITH CLOT FROM THE HYPOGASTRIC ARTERY TO THE FLOW DIVIDER. DUE TO THE SEVERE ANGLE/TORTUOSITY OF THE LCIA THE PHYSICIAN DECIDED TO SIMPLY PERFORM A FEM-FEM- BYPASS AND AVOID ANY POTENTIAL FUTURE RE-CLOTTING ISSUES. ACCORDING TO PHYSICIAN THE PATIENT HAS NO CLOTTING ISSUE AND STATED THAT THE CLOTTING EVENT OCCURRED DUE TO THE SEVERE ANGLE IN THE LCIA. BLOOD FLOW HAS BEEN RESTORED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE REVIEW OF RETURNED CTA¿S FROM 5-MONTHS POST-IMPLANT REVEALED THAT THE BIFURCATE WAS POSITIONED JUST BELOW THE RENALS. THE IPSI LIMB AND EXTENSION WERE PLACED INTO THE RIGHT COMMON ILIAC, AND THE CONTRA LIMB INTO THE LEFT COMMON ILIAC. THE ENTIRE CONTRA LIMB IS OCCLUDED BEGINNING AT THE BIFURCATE FLOW DIVIDER. THE LEFT SIDE DISTAL FLOW RESUMES AT THE LEFT EXTERNAL. THE RIGHT LIMB IS PATENT. AT THE ORIGIN OF THE LEFT COMMON ILIAC ARTERY, THE CONTRA LIMB IS ACUTELY ANGULATED APPROXIMATELY 150DEG LATERALLY AND THE LIMB IS KINKED DOWN TO <(> <<)>10MM OD AT THIS ANGULATION. PRIOR TO THE KINK THE CONTRA LIMB OD IS APPROX 19MM, AND POST KINK MEASURES 24MM. IT IS LIKELY THAT THE CAUSE OF THE OCCLUSION IS RELATED TO STENT GRAFT PLACEMENT WITHIN THE ANGULATED ILIAC ARTERY. IMAGES POST FEM-FEM BYPASS INTERVENTION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726069 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04183965

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Required Intervention