BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3173905 · Received June 17, 2013

    Report

    Report Number
    2953200-2013-01138
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 23, 2013
    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). METHODS: FILMS. RESULTS: NARROWED DISTAL LEFT ILIAC. STENT GRAFT OCCLUSION. LANDING IN THE NARROWED DISTAL LEFT ILIAC. CONCLUSIONS: NARROWED DISTAL LEFT ILIAC. STENT GRAFT OCCLUSION. LANDING IN THE NARROWED DISTAL LEFT ILIAC.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50.5 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 25.7-28.5 MM IN DIAMETER AND 33 MM IN LENGTH. THE DISTAL AORTA WAS 46MM IN DIAMETER. THE LEFT ILIAC ARTERY DIAMETER WAS 18MM PROXIMALLY AND 15MM DISTALLY. THE LEFT FEMORAL ARTERY WAS 8MM IN DIAMETER. THE RIGHT ILIAC ARTERY DIAMETERS WERE 36-29-23.5MM. THE RIGHT FEMORAL ARTERY DIAMETER WAS 9MM. THE RIGHT ILIAC ARTERY WAS SEVERELY CALCIFIED, AND THE LEFT ILIAC ARTERY WAS MILDLY CALCIFIED. THE RIGHT INTERNAL ILIAC ARTERY WAS INTENTIONALLY COVERED AND COILED DURING THE IMPLANT. IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST IMPLANT THE LEFT LIMB WAS FOUND TO BE OCCLUDED WITH THROMBUS. A THROMBECTOMY AND STENTING WERE PERFORMED, AND THE OCCLUSION RESOLVED. THE PHYSICIAN NOTED THAT ALTHOUGH THE ORIGINAL FILMS LOOKED OKAY, THERE WAS COMPRESSION OF THE DISTAL PORTION OF THE LEFT LIMB. THIS WAS DUE TO THE 20MM FLARED END LANDING IN THE NARROWED DISTAL LEFT ILIAC. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE. A REVIEW OF RETURNED FILMS PRE-IMPLANT SHOWED A 5CM AAA WHICH WAS CALCIFIED AND CONTAINED THROMBUS. THE RIGHT COMMON ILIAC WAS ANEURYSMAL; MEASURED 3.4CM MAX DIAMETER. THE LEFT COMMON ILIAC DIAMETER MEASURED APPROXIMATELY 18-19MM AT THE ORIGIN, NARROWING TO 14-15MM AT THE DISTAL END, AND WAS CALCIFIED. FILM POST-STENT GRAFT IMPLANT WERE NOT PROVIDED; THEREFORE THE REPORTED OCCLUSION COULD NOT BE ASSESSED. IT IS POSSIBLE THAT PLACEMENT OF THE 20MM STENT GRAFT INTO THE DISTAL NARROWED PORTION OF THE CALCIFIED LEFT COMMON ILIAC MAY HAVE CONTRIBUTED TO THE OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274406 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04005949

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention