BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT II

    MDR report key: 3910171 · Received July 2, 2014

    Report

    Report Number
    2953200-2014-01349
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    June 7, 2014
    Report Date
    June 8, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 > 6 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE NECK WAS 19 MM IN DIAMETER AND 10 MM IN LENGTH WITH AN ANGULATION OF 10 DEGREES. IT WAS REPORTED THAT THE PATIENT RETURNED TO THE HOSPITAL IN PAIN WITH A CONTAINED RUPTURE FROM A PROXIMAL TYPE I ENDOLEAK. THE ENDOLEAK WAS ATTRIBUTED TO STENT GRAFT INFOLD. THE STENT GRAFT WAS OVER SIZED BECAUSE THE NECK WAS SHORT AND WENT FROM 19MM-30MM IN A LESS THAN 10 MM OF LENGTH. NO ENDOLEAK OR OTHER ISSUES WERE SEEN AT THE TIME OF IMPLANT. THE PATIENT UNDERWENT EMERGENCY ENDOVASCULAR REPAIR WITH ANOTHER MANUFACTURER¿S STENT (PALMAZ) WHICH WAS UNSUCCESSFUL. AN ENDURANT CUFF WAS IMPLANTED; HOWEVER, THE PATIENT EXPIRED AFTER 16 MINUTES OF CHEST COMPRESSIONS. PRE-IMPLANT CTA'S WERE REVIEWED. FILMS WERE NON-CONTRAST; MEASUREMENTS ARE APPROXIMATE AND ANY AMOUNTS OF THROMBUS COULD NOT BE APPRECIATED. THERE IS A 5.5CM MAX DIAMETER AAA, WHICH WAS RINGED WITH CALCIFICATION. THE PROXIMAL NECK DIAMETER WAS 30MM AND THE NECK WAS SHORT AND CONICALLY SHAPED. THERE WAS LITTLE NECK ANGULATION. THE SUPRARENAL AORTIC DIAMETER NEAR THE CELIAC WAS 26MM AND RINGED WITH CALCIFICATION. THE DISTAL AORTIC DIAMETER WAS VERY SMALL (8MM MINIMUM DIAMETER) AND WAS ALSO CALCIFIED. THE ILIACS WERE ALSO SEVERELY CALCIFIED. IMAGES DURING THE IMPLANT REVEALED THAT THE PROXIMAL NECK DIAMETER FLOW LUMEN WAS APPROXIMATELY 21MM (L-R) AND THE NECK LOOKED 'SHAGGY' LIKELY DUE TO THROMBUS. THE DISTAL AORTIC FLOW LUMEN WAS 12MM. THE MAIN DEVICE WAS BROUGHT UP THE RIGHT SIDE; THE BIFURCATE WAS PLACED JUST BELOW THE RENALS. NO ISSUES WERE SEEN WITH THE SUPRARENAL STENTS PRIOR TO TIP RELEASE. AN IMAGE AFTER TIP RELEASE SHOWS THAT THE TIP IS POSITIONED ABOVE THE SUPRARENAL STENTS, AND THE SPINDLE IS AT THE LEVEL OF THE PINS ON THE LEFT SIDE. FINAL ANGIO SHOWS THAT 2 OR MORE OF THE SUPRARENAL STENTS ON THE LEFT SIDE MAY NOT HAVE COMPLETELY OPENED, AND MAY BE ENTANGLED OR RETAINED BY THE SUPRARENAL AORTA AND THROMBUS. NO ENDOLEAK IS SEEN. POST-IMPLANT ANGIO STUDY REVEALED A PROXIMAL TYPE I ENDOLEAK. TWO OR MORE OF THE SUPRARENAL STENTS APPEARED NOT TO HAVE COMPLETELY OPENED OR ARE ENTANGLED (SIMILAR TO THE APPEARANCE AT IMPLANT). THE SUPRARENAL AORTIC ID AT THE LEVEL OF THE SUPRARENAL PINS IS 22MM, AND THE PROXIMAL STENT GRAFT OD IS 33MM. ANOTHER MANUFACTURER¿S STENT OR STENT GRAFT AND ONE OR POSSIBLY 2 CUFFS WERE PLACED (OTHER MANUFACTURER¿S CUFF). NO ADDITIONAL IMAGES WERE PROVIDED. THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK IS UNKNOWN, BUT WAS LIKELY DUE TO THE INFOLDING OF THE PROXIMAL GRAFT CAUSED BY ONE OR MORE OF THE SUPRARENAL STENTS NOT COMPLETELY OPENING OR BECOMING ENTANGLED AT IMPLANT. IT IS POSSIBLE THAT THE PROXIMAL NECK ANATOMY (SHORT AND SEVERELY CONICAL SHAPED WITH THROMBUS) MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387013 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04086974

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| R