BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT

    MDR report key: 3971741 · Received July 31, 2014

    Report

    Report Number
    2953200-2014-01492
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 9.5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS A VERY CONICAL AND SHORT PROXIMAL AORTIC NECK 23 MM IN DIAMETER AT THE RENAL ARTERIES AND 33 MM IN DIAMETER 11 MM BELOW THE RENAL ARTERY (THE LENGTH OF THE AORTIC NECK, VERY BORDERLINE ANATOMY. THE PHYSICIAN ELECTED TO ATTEMPT TO TREAT THE PATIENT WITH STENT GRAFTS. THE BIFURCATED STENT GRAFT MOVED DURING DEPLOYMENT, BECAUSE OF THE SHORT AORTIC NECK AND THE FACT THAT IT APPARENTLY WIND SOCKED BEFORE THE GATE WAS OPENED AND FLOW THROUGH THE GRAFT ESTABLISHED. THIS NECESSITATED IMPLANTING AN ENDURANT AORTIC CUFF 36X36X49. THE PHYSICIAN INTENTIONALLY IMPLANTED THE AORTIC CUFF ENCROACHING ON THE LEFT RENAL ARTERY. HOWEVER, IT ENCROACHED ON THE LEFT RENAL SIGNIFICANTLY, BUT UNKNOWN AT THE TIME, IT WAS AN ACCESSORY RENAL, NOT THE MAIN RENAL. THE PHYSICIAN IMPLANTED A STENT IN THE MAIN RENAL, THINKING IT WAS COVERED BY THE GRAFT, BUT IT WAS ACTUALLY THE LOWER RENAL THAT WAS MOSTLY COVERED. THERE WAS A RESIDUAL PROXIMAL TYPE I ENDOLEAK AFTERWARD, BUT BECAUSE OF THE BARE METAL STENT IN THE MAIN RENAL ARTERY, THERE WAS NO OPTION TO PLACE ANOTHER CUFF. THE AORTIC CUFF WAS PROBABLY 2-3 MM BELOW THE BOTTOM OF THE MAIN RENAL WHICH HAD THE ATRIUM 6 X 22 STENT. THE PHYSICIAN MODELLED THE STENT GRAFTS MORE AGGRESSIVELY AND THE PROXIMAL TYPE I ENDOLEAK WAS ALMOST GONE, VERY FAINT. THE PHYSICIAN WILL MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED PRE-IMPLANT CTA'S REVEALED THAT THE PROXIMAL AORTIC NECK DIAMETER (FLOW LUMEN) WAS APPROXIMATELY 23MM JUST BELOW THE LEFT RENAL, VERY SHORT (APPROX. 1CM LENGTH) AND CONICAL. THE PROXIMAL AORTIC NECK ANGULATION WAS STRAIGHT L-R, BUT ANGULATED APPROXIMATELY 90 DEG (A-P). THE MAX DIAMETER AAA MEASURED 9.5 CM, AND WAS RINGED WITH CALCIFICATION. THE DISTAL AORTIC NECK WAS 2CM X 3CM AND CALCIFIED, AND BOTH ILIACS WERE VERY TORTUOUS AND SHORT. IMAGES DURING THE REPORTED EVENT AT IMPLANT WERE NOT PROVIDED. THE CAUSE OF THE INACCURATE DELIVERY IS UNKNOWN, BUT IT IS POSSIBLE THAT THE SHORT AND CONICAL PROXIMAL NECK MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447635 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04653904

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR