BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3841612 · Received May 30, 2014

    Report

    Report Number
    2953200-2014-01099
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 APPROXIMATELY FOUR YEARS AGO. IT WAS REPORTED THAT THE PATIENT HAD A CT NOTING THAT THE ANEURYSM WAS 6.5 CM IN DIAMETER. THERE WAS EVIDENCE OF STENT GRAFT STENOSIS. THERE WAS ALSO EVIDENCE OF AN UNDETERMINED ENDOLEAK.

    Description of Event or Problem · 1

    FILM EVALUATION: A REVIEW OF NON-CONTRAST CTA'S 4 YEARS POST-IMPLANT REVEALED THAT AN ENDURANT AUI AND EXTENSION WERE IMPLANTED INTO THE RIGHT COMMON ILIAC ARTERY. THE PROXIMAL NECK IS ESSENTIALLY STRAIGHT. THE PROXIMAL STENT GRAFT OD IS 20MM, AND THERE IS APPROXIMATELY 1CM OF PROXIMAL SEAL LENGTH. THE MAX DIAMETER AAA IS 5.7CM. THE DISTAL AORTIC DIAMETER IS APPROXIMATELY 18MM AND CALCIFIED, AND THE STENT GRAFT ID IN THIS LOCATION IS 11MM. THERE IS ALSO SIGNIFICANT CALCIFICATION SEEN ALONG THE LENGTH OF THE RIGHT COMMON ILIAC. OTHER THAN LATERAL LIMB ANGULATION OF 55DEG WITHIN THE RIGHT ILIAC, THE STENT GRAFT IS ESSENTIALLY STRAIGHT. NO STENT GRAFT KINKS OR COMPRESSION IS SEEN. AS THESE ARE NON-CONTRAST IMAGES, ANY POSSIBLE ENDOLEAK OR STENT GRAFT STENOSIS/OCCLUSION COULD NOT BE ASSESSED. X-RAYS ALSO SHOW AN ESSENTIALLY STRAIGHT AUI WITH A GRADUALLY CURVED ILIAC LIMB. THERE IS SUFFICIENT OVERLAP (APPROXIMATELY 3.5CM) BETWEEN THE AUI AND EXTENSION. NO STENT GRAFT ISSUES ARE SEEN. SEVERAL STILL ULTRASOUND IMAGES FROM THE ABDOMINAL STUDY WERE ALSO REVIEWED, BUT THE IMAGES COULD NOT CONFIRM ANY ENDOLEAK OR THE REPORTED STENT GRAFT STENOSIS. THE CAUSE OF THE REPORTED ENDOLEAK AND STENOSIS COULD NOT BE DETERMINED FROM THE IMAGES PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318700 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00266250

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR