BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT SYSTEM

    MDR report key: 2823291 · Received November 7, 2012

    Report

    Report Number
    2953200-2012-02144
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTORNIC IRELAND
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHODS: (FILMS). RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; ILIAC STENOSIS AND CALCIFICATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; ILIAC STENOSIS AND CALCIFICATION).

    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. THERE WAS TIGHT ILIAC STENOSIS AND A LOT OF CALCIUM BILATERALLY. THE LEFT MID COMMON ILIAC ARTERY ALSO HAD A SMALL BEND IN ADDITION TO THE STENOSIS. THE BIFURCATED STENT GRAFT WAS IMPLANTED ON THE RIGHT SIDE AND THE CONTRALATERAL LIMB WAS ON THE LEFT, BOTH STENT GRAFTS WERE IMPLANTED WITHOUT COMPLICATION. IT WAS REPORTED THAT POST IMPLANT THE LEFT SIDE HAD SLOW FLOW BECAUSE OF THE TIGHT STENOSIS AND THE BEND IN THE MID ILIAC ARTERY. THE PHYSICIAN DECIDED TO IMPLANT AN 8 X 4 BALLOON EXPANDABLE STENT IN THIS AREA AND THIS SUCCESSFULLY RESOLVED THE SLOW BLOOD FLOW. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE REVIEW OF SEVERAL RETURNED STILL ANGIOGRAM IMAGES WERE INCONCLUSIVE TO THE CAUSE OF THE ENDOLEAK. OTHER THAN A SLIGHTLY KINKED/COMPRESSED DISTAL CONTRA LIMB (3 STENT RINGS FROM THE END), NO OTHER STENT GRAFT ISSUES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT II STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTORNIC IRELAND V01700583

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention