BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4102982 · Received September 19, 2014

    Report

    Report Number
    2953200-2014-01866
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE STENT GRAFT WAS BALLOONED POST IMPLANT. IT WAS REPORTED THAT A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. IT APPEARS THE GRAFT HAS A CHANNEL LEAK AND IS EITHER INVERTED OR ONE OF THE SUPRA RENAL STENTS HAS INVERTED PULLING THE GRAFT OFF THE WALL CREATING AN ENDOLEAK. THE PHYSICIAN DECIDED TO INTERVENE AND IMPLANTED A PALMAZ STENT GRAFT RESOLVING THE PROXIMAL TYPE I ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. FILM REVIEW ANALYSIS: REVIEW OF RETURNED CTA¿S FROM 2 WEEKS POST-IMPLANT REVEALED THAT THE BIFURCATE WAS POSITIONED JUST BELOW THE LOWEST RIGHT RENAL ARTERY. THE ENTIRE AORTIC BODY IS INFOLDED DOWN TO THE FLOW DIVIDER, AND THERE IS A RESULTING PROXIMAL TYPE I ENDOLEAK. THE PROXIMAL STENT GRAFT MARKERS WERE ALIGNED ON THE SAME PLANE AND THERE WAS NO SUPRARENAL STENT ENTANGLEMENT OBSERVED. THE IPSI LIMB WAS PLACED INTO THE RIGHT COMMON ILIAC, AND THE CONTRA LIMB INTO THE LEFT COMMON ILIAC. THE PROXIMAL STENT GRAFT OD AT THE LEVEL OF THE RIGHT RENAL IS 22 X 25MM, AND THE NECK CONTAINS THROMBUS AND CALCIFICATION. THE MAXIMUM DIAMETER AAA IS 5.4CM. BOTH LIMBS ARE PATENT. THE CAUSE OF THE INFOLDING COULD NOT BE DETERMINED. IMAGES DURING IMPLANT WERE NOT PROVIDED. IT IS POSSIBLE THAT THE PROXIMAL NECK ANATOMY (SMALL DIAMETER WITH THROMBUS AND CALCIFICATION) MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584316 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04126732

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention