BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2050860 · Received April 1, 2011

    Report

    Report Number
    2953200-2011-00739
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (ARTERIAL OCCLUSION). RESULTS/CONCLUSIONS: (TORTUOUS ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 47 MM DIAMETER ABDOMINAL AORTIC ANEURYSM ON (B)(6), 2011. THE AORTIC NECK IS 30-31 MM IN DIAMETER PROXIMALLY AND 30-32 MM DISTALLY. THE AORTA AND ILIAC ARTERIES WERE EXTREMELY TORTUOUS AND THE LUNDERQUIST WIRES THAT WERE USED DURING THE PROCEDURES WERE NOT ABLE TO STRAIGHTEN OUT THE VESSELS. EVENTUALLY THE STENT GRAFT WAS ABLE TO BE DEPLOYED; HOWEVER, THERE WAS A SMALL TYPE I LEAK THAT WAS NOT NOTICEABLE IN LAO PROJECTION, BUT IT WAS VISIBLE IN AN AP VIEW WHEN THEY WERE LOOKING AT THE ILIAC STENOSIS. ANOTHER MFR'S BALLOON EXPANDABLE STENT WAS DEPLOYED IN THE RIGHT ILIAC AFTER THE ENDURANT STENT GRAFT WAS IMPLANTED TO ADDRESS THE STENOSIS. THE PHYSICIAN WAS UNABLE TO ADVANCE A RELIANT BALLOON UP THE ILIACS, PARTLY BECAUSE THE LUNDERQUIST WIRES MIGHT HAVE BEEN TOO WORN OUT DURING THE PROCEDURE, AND LARGELY BECAUSE OF THE ILIAC TORTUOUSITY. FURTHER REVIEW WITH CT SCAN IS PLANNED IN 5-6 WEEKS POST OPERATIVE. NO FURTHER INTERVENTION WAS PERFORMED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00821315

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention