BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3130763 · Received May 24, 2013

    Report

    Report Number
    2953200-2013-01008
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION). PATIENT¿S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (NARROW TERMINAL AORTA). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (NARROW TERMINAL AORTA).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT IS UNKNOWN. CURRENTLY IT WAS REPORTED A PROXIMAL NECK DIAMETER OF 19MM AND 27MM IN LENGTH. THE ANEURYSM DIAMETER WAS 62MM AND THE ANEURYSM LENGTH TO BIFURCATION WAS 96MM. THE RIGHT ACCESS VESSEL WAS 11MM AND THE DIAMETER OF THE RIGHT BIFURCATED INTERNAL ILIAC VESSEL WAS 16MM. THE RIGHT COMMON ILIAC LENGTH WAS 76MM. THE VESSEL DIAMETER OF THE LEFT ACCESS WAS 12MM AND THE DIAMETER OF THE LEFT BIFURCATED INTERNAL ILIAC VESSEL WAS 13MM. THE LEFT COMMON ILIAC LENGTH WAS 96MM. IT WAS REPORTED THAT THE PATIENT PRESENTED A CONTRA LIMB OCCLUSION DUE TO THE TERMINAL AORTA BEING NARROW 16-17MM IN DIAMETER WHICH CAUSED THE CONTRALATERAL LIMB TO PARTIALLY OCCLUDE. THERE IS NO ADDITIONAL TREATMENT AT THIS TIME AND THE PATIENT WILL REMAIN UNDER OBSERVATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231213 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR