BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2990411 · Received March 5, 2013

    Report

    Report Number
    2953200-2013-00415
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION , RESULTS AND CONCLUSION: (ENDOLEAK). (UNKNOWN CAUSE OF ENDOLEAK).

    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 A 60 MM ABDOMINAL AORTIC ANEURYSM APPROX IMATELY ONE MONTH AGO. THE PROXIMAL AORTIC NECK WAS 28MM IN DIAMETER, AND 20MM LONG. IT WAS REPORTED THAT INTRA-OPERATIVELY A CONTROL ANGIO WITH CONTRAST REVEALED AN ENDOLEAK. THE PHYSICIAN BELIEVES THE ENDOLEAK WAS A TYPE III. THE STENT GRAFT WAS BALLOONED WITH A RELIANT BALLOON AND THE PROCEDURE WAS COMPLETED. A CT WAS DONE THE FOLLOWING DAY AND SHOWED NO EVIDENCE OF AN ENDOLEAK. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    FILM REVIEW OF RETURNED ANGIO IMAGES AT IMPLANT SHOW THAT THE BIFURCATE WAS BROUGHT UP THE LEFT SIDE. THE CONTRALATERAL LIMB WAS OVERLAPPING THE GATE AND ALIGNED WITH THE GATE MARKERS. AN ENDOLEAK IS SEEN IN THE UPPER RIGHT SIDE OF THE AAA; APPROXIMATELY 1CM ABOVE THE FLOW DIVIDER, IN AN AREA OF THE AORTIC BODY WHERE THE STENT GRAFT DIAMETER BEGINS TO NARROW DOWN. THE ENDOLEAK HAS THE APPEARANCE OF A BLUSH TYPE IV ENDOLEAK, BUT CANNOT RULE OUT A PROXIMAL TYPE I OR TYPE III FABRIC. FILMS POST-IMPLANT ONE DAY POST IMPLANT DO NOT SHOW ANY ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92841 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03035540

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR