BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2181217 · Received July 22, 2011

    Report

    Report Number
    2953200-2011-01328
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (IMPLANTATION INTO A PATIENT WITH A SEVERELY ANGULATED NECK), (ENDOLEAK, MIGRATION). CONCLUSION: (ANGULATION OF NECK).

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED IN A PATIENT FOR A SLOW GROWING, GREATER THAN 5 CM IN DIAMETER ABDOMINAL ANEURYSM, APPROXIMATELY 18 WEEKS AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 24-26 MM IN DIAMETER FOR ABOUT 1 CM IN LENGTH, THEN HAD A SEVERE BEND OF 60-70 DEGREES AND ENLARGED TO 30 MM IN DIAMETER WITH MILD CALCIFICATION AND THROMBUS. THE ILIAC ARTERIES WERE NON-TORTUOUS BUT VERY HARD AND CALCIFIED. THE FEMORAL ARTERIES WERE 3 MM IN DIAMETER AND THERE WAS A PATENT IMA. COMORBIDITIES INCLUDES HIGH CREATININE AND OSTEOPOROSIS, COMPRESSED VERTEBRAE/SPONDYLOSIS, AND LEFT-RIGHT CURVATURE OF THE SPINE. THE AORTA FOLLOWED THE CURVATURE OF THE SPINE. THE PATIENT WAS NOT AN OPEN SURGICAL REPAIR CANDIDATE. THE ENDURANT BIFURCATED STENT GRAFT AND CONTRALATERAL LIMB WERE IMPLANTED WITHOUT ISSUES, WITH PROXIMAL PLACEMENT RIGHT AT THE RENALS. AN ULTRASOUND WAS PERFORMED THREE OR FOUR MONTHS AFTER IMPLANT, RATHER THAN A FOLLOW UP CT, DUE TO THE PATIENT'S INABILITY TO HANDLE CONTRAST MEDIA. THE ULTRASOUND SHOWED WHAT MAY HAVE BEEN AN ENDOLEAK AND SAC ENLARGEMENT. AN ANGIOGRAM CONFIRMED A PROXIMAL TYPE I ENDOLEAK, AS THE STENT GRAFT HAD MIGRATED APPROXIMATELY 1 CM DISTALLY, WITH THE SUPRARENAL STRUTS BELOW THE LOWEST RENAL. THE AAA WAS FOUND TO HAVE ENLARGED TO 6 CM. AN ENDURANT 32X32X49 CUFF WAS PLACED PROXIMALLY AT THE RENALS AND BALLOONED WITH ANOTHER MANUFACTURER'S BALLOON WHICH RESOLVED THE PROXIMAL TYPE I ENDOLEAK. SEVERAL MORE SCANS FROM DIFFERENT ANGLES CONFIRMED THE RESOLUTION OF THE ENDOLEAK. THE MIGRATION WAS LIKELY RELATED TO THE CHALLENGING NECK ANATOMY. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00804844

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention