BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2093649 · Received April 6, 2011

    Report

    Report Number
    2953200-2011-00752
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 7, 2011
    Report Date
    March 7, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RESULTS: (ENDOLEAK).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS A SLIGHT ANGULATION OF THE AORTIC NECK, THERE WAS MILD TORTUOSITY, MILD THROMBUS AND MILD CALCIFICATION IN THE ILIAC ARTERIES. PRIOR TO THE STENT GRAFT PROCEDURE, THE PATIENT HAD BALLOON EXPANDABLE PERIPHERAL STENTS IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY. THE ENDURANT STENT GRAFT WAS IMPLANTED; HOWEVER, UPON FINAL ANGIOGRAM, THERE WAS A TYPE IV ENDOLEAK, THE ENDOLEAK WAS A BLUSH AT THE LEVEL OF THE JUNCTION OF THE BIFURCATED STENT GRAFT. THE PATIENT WILL BE MONITORED. CURRENTLY THERE HAS BEEN NO FURTHER INTERVENTION PERFORMED FOR THIS PATIENT. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00564779

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR