BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3292159 · Received August 16, 2013

    Report

    Report Number
    2953200-2013-01571
    Event Type
    Injury
    Date Received
    August 16, 2013
    Date of Event
    July 20, 2013
    Report Date
    July 20, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FILM REVIEW. RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION); PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; NARROWING AND SEVERE CALCIFICATION OF THE EXTERNAL ILIAC). CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (OCCLUSION); DEVICE FAILURE RELATED TO PATIENT CONDITION (ANATOMY RELATED; NARROWING AND SEVERE CALCIFICATION OF THE EXTERNAL ILIAC).

    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. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH A THROMBECTOMY OF THE ILIAC LIMB DUE TO THE NARROWING AND SEVERE CALCIFICATION OF THE EXTERNAL ILIAC. THE PHYSICIAN ELECTED TO RELINE WITH AN ENDURANT STENT GRAFT 161393 AND THE INTERVENTION WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF 2 RETURNED STILL CTA IMAGES CONFIRMED THAT THE LEFT ILIAC LIMB WAS OCCLUDED, WITH POSSIBLE STENT GRAFT COMPRESSION SEEN IN THE DISTAL END OF THE LIMB. THE CAUSE COULD NOT BE DETERMINED FROM THESE IMAGES. POSSIBLE CONTRAST WAS SEEN OUTSIDE THE PATENT LIMB; COULD NOT CONFIRM IF THIS MAY BE A POSSIBLE (UNKNOWN TYPE) ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397396 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03021754

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention