BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2102391 · Received May 20, 2011

    Report

    Report Number
    2953200-2011-01024
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK; UNKNOWN TYPE OF ENDOLEAK. CONCLUSIONS: UNKNOWN TYPE OF ENDOLEAK.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.3 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS REPORTED AS VERY SMALL, SEVERELY CALCIFIED ILIACS, WITH TORTUOSITY. THE STENT GRAFTS WERE SUCCESSFULLY IMPLANTED IN THE PATIENT. THE FINAL ANGIOGRAM WAS RUN AND THERE WAS A SLIGHT (LATE) TYPE IV ENDOLEAK. THE PATIENT WILL BE MONITORED IN 30 DAYS. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. FILM EVALUATION: REVIEW OF FILMS AT IMPLANT SHOW AN ENDOLEAK, WHICH APPEARS MORE "JETTING" IN APPEARANCE, EMANATING FROM JUST BELOW THE BIFURCATED STENT GRAFT GATE; POSSIBLE TYPE IV, BUT CANNOT RULE OUT TYPE III ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00833727

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR