BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4152868 · Received October 8, 2014

    Report

    Report Number
    2953200-2014-02009
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 14, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON REGULAR FOLLOW-UP ANEURYSM GROWTH WAS NOTED. THE ANEURYSM HAD INITIALLY SHRUNK FROM 9.5CM TO 7CM AS NOTED ON PREVIOUS FOLLOW-UP; HOWEVER, DURING THE RECENT EVALUATION IT WAS BACK UP TO 9.5CM IN DIAMETER. THE PATIENT WAS SENT FOR CT SCAN WHICH SHOWED LIMB DISUNION BETWEEN THE 16/24/124 AND THE 20/20/82 ENDURANT LIMB STENT GRAFTS WITH A LARGE ENDOLEAK PRESENT. THE CAUSE OF THE SEPARATION IS UNKNOWN, BUT IS LIKELY DUE TO INSUFFICIENT STENT GRAFT OVERLAP. AN ENDURANT 16/24/199 STENT GRAFT WAS PLACED INSIDE BOTH STENT GRAFTS TO BRIDGE THE GAP BETWEEN THE LIMBS AND RE-LINING THE ENTIRE LENGTH OF BOTH PREVIOUSLY PLACED STENT GRAFTS. THE FINAL ANGIOGRAM SHOWED COMPLETE RESOLUTION OF ENDOLEAK WITH 9CM OF OVERLAP IN THE 16/24/124 AND 8CM OF OVERLAP IN THE 20/20/82. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF FILMS FROM OVER TWO YEARS POST-IMPLANT REVEALED THAT THE BIFURCATE WAS POSITIONED JUST BELOW THE RENAL ARTERIES. THE PROXIMAL NECK WAS ANGULATED APPROXIMATELY 55 DEGREES MAXIMUM TO THE ILIAC ARTERIES (A-P). THE IPSILATERAL LIMB AND EXTENSION WERE PLACED INTO THE RIGHT COMMON ILIAC ARTERY. LIMB SEPARATION WITH A TYPE III ENDOLEAK WAS OBSERVED BETWEEN THE CONTRALATERAL LIMB AND THE CONTRALATERAL LIMB EXTENSION. WITHIN THE MID ANEURYSM SAC, THE 24 X 28MM DISTAL OD OF THE CONTRALATERAL LIMB HAS DETACHED FROM THE 21MM PROXIMAL OD OF THE CONTRALATERAL EXTENSION. THE AMOUNT OF LIMB SEPARATION WAS APPROXIMATELY 2CM AND THE LIMBS WERE ALSO NOT ALIGNED TO EACH OTHER. THE DISTAL END OF THE CONTRALATERAL LIMB EXTENSION WAS POSITIONED WITHIN THE LEFT COMMON ILIAC ARTERY. BOTH THE CONTRALATERAL AND IPSILATERAL LIMBS WERE PATENT. THE MAXIMUM DIAMETER AAA MEASURED 8.9CM. NOTABLE ANGULATION (90 DEGREES L-R) WAS OBSERVED BETWEEN THE PROXIMAL CONTRALATERAL LIMB (WITHIN THE GATE) AND THE BIFURCATE AORTIC BODY, AND 90 DEGREE R-L ANGULATION WAS SEEN BETWEEN THE MID AND DISTAL END OF THE CONTRALATERAL LIMB. THE EXACT CAUSE OF THE SEPARATION IS UNKNOWN. IT IS POSSIBLE THAT THERE WAS MINIMAL OVERLAPPING LENGTH BETWEEN THE TWO LIMBS, AND ANEURYSM MORPHOLOGY CHANGES LEADING TO SEVERE LIMB ANGULATION AT THE COMPONENT OVERLAP MAY HAVE ALSO CONTRIBUTED TO THE SEPARATION. EARLIER POST-IMPLANT IMAGES AND FILMS POST-TREATMENT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630923 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01039647

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention