BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2950615 · Received February 8, 2013

    Report

    Report Number
    2953200-2013-00207
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: STENT GRAFT OCCLUSION. TORTUOUS, NARROW AND CALCIFIED ILIAC ARTERY. CONCLUSION: TORTUOUS, NARROW AND CALCIFIED ILIAC 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 APPROXIMATELY SEVEN WEEKS AGO. THE LEFT COMMON ILIAC ARTERY HAD A 90 DEGREE ANGULATION. IT WAS NARROW DUE TO CALCIFICATION AND WAS 10MM IN DIAMETER. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP CT SCAN THERE WAS OCCLUSION IN THE LEFT LIMB. THE OVERLAPPED AREA BETWEEN THE 1616 AND THE 1610 WAS OCCLUDED. THE NEXT DAY A THROMBECTOMY WAS PERFORMED WITH A FOGARTY CATHETER; HOWEVER, IT WAS NOT POSSIBLE TO COMPLETELY REMOVE THE THROMBUS DUE TO THE SEVERELY ANGULATED COMMON ILIAC ARTERY. THREE DAYS LATER A FEM-FEM BYPASS WAS PERFORMED AND RESOLVED THE OCCLUSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54309 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01725524

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention