BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3955884 · Received July 24, 2014

    Report

    Report Number
    2953200-2014-01455
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 51X48MM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE PROXIMAL AORTIC NECK IS 27MM RIGHT BELOW THE RENAL ARTERIES AND 29MM AT THE ANEURYSM ENTRY. THE PROXIMAL AORTIC NECK LENGTH IS 15MM. DURING THE INDEX PROCEDURE AND WHILE CANNULATING THE GATE, THE PHYSICIAN NOTICED THE MAIN BODY STENT GRAFT WAS IN-FOLDED. POST OP, THE PHYSICIAN USED A BALLOON AND WATCHED THE MARKERS MOVE SIGNIFICANTLY, MARKERS EXPANDED AND THE DEVICE LANDED AT THE INTENDED LANDING ZONE JUST BELOW THE RENAL ARTERIES. A TYPE IA ENDOLEAK WAS ALSO CONFIRMED. THE PHYSICIAN DECIDED TO ADD ANOTHER MANUFACTURER¿S STENT AND THE ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. THE REVIEW OF PRE-IMPLANT ANGIO AND NON-CONTRAST CTA IMAGES REVEALED A SEVERELY ANGULATED PROXIMAL NECK; APPROX 90DEG (L-R). THE NECK WAS CALCIFIED AND THERE WAS A SHARP LEDGE ON THE RIGHT INNER CURVED SECTION OF THE DISTAL NECK. THE FLOW LUMEN DIAMETER (L-R) JUST BELOW THE RENALS MEASURED 24MM, AND AT THE LEVEL OF THE SHELF/DISTAL NECK MEASURED 19MM. SEVERAL STILL ANGIO IMAGES AT IMPLANT, WITHOUT CONTRAST, SHOWED THAT THE BIFURCATE PROXIMAL MARKERS APPEARED TO BE ALONG THE SAME PLANE. THERE WAS SLIGHT ANGULATION BETWEEN THE 1ST/2ND COVERED STENT, HOWEVER, THE REPORTED INFOLDING AND TYPE IA ENDOLEAK COULD NOT BE CONFIRMED FROM THESE LIMITED NON-CONTRAST IMAGES. IMAGES DURING THE CANNULATION AND BALLOONING WERE NOT SEEN IN THE FILMS, AND THERE WAS NO SCALE ON THE FILMS TO MAKE ANY MEASUREMENTS. A SECOND IMAGE SHOWS THAT A STENT HAD BEEN IMPLANTED WITHIN THE AORTIC BODY, AND THE PROXIMAL MARKERS APPEARED TO HAVE SLIGHTLY EXPANDED RADIALLY AND THE AORTIC BODY MAY HAVE STRAIGHTENED. THE CAUSE OF THE REPORTED INFOLDING/ENDOLEAK COULD NOT BE DETERMINED. ADDITIONAL IMAGES AT IMPLANT AND POST-IMPLANT IMAGES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432989 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04231960

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR Required Intervention