BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3181981 · Received June 21, 2013

    Report

    Report Number
    2953200-2013-01164
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 23, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: (FILM). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK); UNAPPROVED USE OF DEVICE (TREATMENT OF A PATIENT WITH AN AORTIC NECK ANGULATION GREATER THAN 60 DEGREES). CONCLUSIONS: INHERENT RISK OF A PROCEDURE (ENDOLEAK); LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK);OFF LABEL-UNAPPROVED OR CONTRAINDICATED USE OF DEVICE (TREATMENT OF A PATIENT WITH AN AORTIC NECK ANGULATION GREATER THAN 60 DEGREES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT AND A RELIANT BALLOON WAS USED FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. CURRENTLY IT WAS REPORTED THAT THE AORTA NECK ANGULATION WAS 60 DEGREES. THE PROXIMAL AORTIC NECK DIAMETER WAS 19MM AND THE DIAMETER OF THE ANEURYSM ENTRY WAS 17MM. THE NECK LENGTH WAS 16MM. THE ANEURYSM DIAMETER WAS 56MM. THE DIAMETER OF THE RIGHT ILIAC VESSEL WAS 17MM AND THE DIAMETER OF THE LEFT ILIAC VESSEL WAS 18MM. AN ANGIOGRAPHY PERFORMED SIX MONTHS LATER REVEALED A TYPE IA OR III ENDOLEAK. THE PHYSICIAN STATED THAT THE ANEURYSM SIZE HAS NOT GROWN SINCE THE INDEX PROCEDURE; THEREFORE, THE PATIENT WILL CONTINUE TO BE UNDER OBSERVATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. A REVIEW OF RETURNED FILMS PRE-IMPLANT SHOW THAT THE PROXIMAL NECK IS ANGULATED TO APPROXIMATELY 85 DEGREES. THE NECK DIAMETER AT THE RENAL ARTERIES IS APPROXIMATELY 20MM, FUNNEL-SHAPED, AND IS CALCIFIED. THE MAX AAA DIAMETER IS 5.5CM, IS CALCIFIED, AND THE ILIACS ARE SEVERELY CALCIFIED. IMAGES 3-WEEKS POST IMPLANT SHOW THAT THE BIFURCATE IS POSITIONED JUST BELOW THE RENAL ARTERIES; THE BIFURCATE AORTIC BODY IS ANGULATED 75DEG TO THE ILIAC LIMBS. THE IPSILATERAL LIMB IS PLACED IN THE LEFT ILIAC, CROSSING OVER THE CONTRA LIMB IN THE DISTAL SAC. CONTRAST IS SEEN WITHIN THE ANEURYSM SAC; THIS APPEARS TO BE A PROXIMAL TYPE I ENDOLEAK BUT CANNOT RULE OUT AN ADDITIONAL FABRIC TYPE III NEAR THE FLOW DIVIDER. IMAGES 6-MONTHS POST-IMPLANT SHOW CONTRAST WITHIN THE ANEURYSM SAC. AS SEEN IN THE EARLIER FOLLOW-UP IMAGES, THE ENDOLEAK APPEARS TO BE A PROXIMAL TYPE I ENDOLEAK BUT CANNOT RULE OUT A FABRIC TYPE III NEAR THE FLOW DIVIDER. THE AAA MAX DIAMETER IS 6.3 X 5.3CM. IT IS LIKELY THAT THE ANGULATED PROXIMAL NECK CONTRIBUTED TO THE LIKELY PROXIMAL TYPE I ENDOLEAK. A FILM REVIEW AND 3D RECON SHOWED THE SCAN RESOLUTION IS POOR WITH 5MM SPACING BETWEEN SLICES, MAKING THE IDENTIFICATION OF THE LEAK ORIGIN, TYPE, AND CAUSE DIFFICULT. THE ENDOLEAK APPEARS TO BE A TYPE III FABRIC LEAK ORIGINATING NEAR THE FLOW DIVIDER OF THE MAIN GRAFT. THE LARGEST BLOOD MASS FROM THE LEAK IS IN THE FRONT OF THE GRAFT BODY. THE SCAN RESOLUTION DOES NOT ALLOW THE DETERMINATION OF STENT INTEGRITY OR ANY OTHER POSSIBLE FACTOR CONTRIBUTING TO THE ENDOLEAK. THE SEAL REGION OF THE GRAFT APPEARS INTACT, WITH NO TYPE I ENDOLEAK PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282138 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00968909

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR