BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3092315 · Received May 3, 2013

    Report

    Report Number
    2953200-2013-00824
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 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). EVALUATION, METHOD: (FILM EVALUATION). RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION, KINK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; TORTUOUS AND CALCIFIED ILIAC ARTERIES). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; TORTUOUS AND CALCIFIED ILIAC ARTERIES).

    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. THE ANEURYSM WAS 54 MM IN DIAMETER. THE AORTIC NECK WAS CONICAL IN SHAPE AND WAS 22.5 MM IN DIAMETER AT THE RENAL ARTERY AND 27 MM IN DIAMETER BELOW THE RENAL ARTERIES. THE DISTAL AORTA IS 29 MM IN DIAMETER. THE LEFT ILIAC ARTERY WAS 8 MM IN DIAMETER. THE LEFT FEMORAL ARTERY WAS 14 MM IN DIAMETER. THE VESSELS WERE VERY DISEASED WITH MODERATE CALCIFICATION. THE ILIAC ARTERIES WERE TORTUOUS. IT WAS REPORTED THAT AT THE INDEX PROCEDURE ACCESS WAS TERRIBLY CHALLENGING, BUT EVENTUALLY THE MAIN BODY GOT UP ON THE LEFT SIDE. THE PATIENT HAD A KINK/MAJOR TURN IN THE ARTERY DAY OF PROCEDURE. WHEN THE PATIENT CAME BACK FOR FOLLOW UP, THE LEFT LIMB WAS VERY STENOSED. THE PHYSICIAN SUCCESSFULLY PLACED A 10 X 38 BARE METAL STENT AND POST DILATED IT WITH A 12MM BALLOON. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF SEVERAL RETURNED STILL ANGIO IMAGES SHOWED THAT THE IPSILATERAL LIMB AND EXTENSION WERE PLACED INTO THE LEFT COMMON ILIAC ARTERY. IMAGES AT THE (ASSUMED) IMPLANT SHOW THAT THE IPSILATERAL LIMB AND THE LEFT EXTENSION IS KINKED LATERALLY (APPROX 90DEGREES) NEAR THE MOST DISTAL STENT OF THE IPSILATERAL LIMB, HOWEVER NO OCCLUSION IS SEEN. A FOLLOW-UP IMAGE (UNK DATE) SHOWS THE KINKED STENT GRAFTS ARE NOW PARTIALLY OCCLUDED AT THE SITE OF THE KINK. THE DISTAL RUNOFF APPEARS OKAY. ANOTHER IMAGE (UNK DATE) SHOWS THAT AFTER A STENT WAS PLACED WITHIN THE KINKED PORTION OF THE IPSILATERAL LIMB AND EXTENSION, THE KINK HAS SLIGHTLY STRAIGHTENED, AND THE OCCLUSION WITHIN THE STENT GRAFT HAS RESOLVED. THE LIKELY CAUSE OF THE KINK/THROMBUS APPEARS TO BE ANATOMY RELATED; TORTUOUS AND DISEASED ILIACS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195033 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03043724

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention