BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 4132574 · Received October 1, 2014

    Report

    Report Number
    2953200-2014-01960
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    August 11, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 23-24 MM IN DIAMETER AND 12 MM IN LENGTH. THE LEFT AND RIGHT COMMON ILIAC ARTERIES WERE 12 MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 9 MM IN DIAMETER AND THE LEFT EXTERNAL ILIAC ARTERY MEASURED 8 MM IN DIAMETER. IT WAS REPORTED THAT 28 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL COMPLAINING OF THE LEG PAIN. THE POST-OPERATIVE CT SCAN SHOWED THE INNER LUMEN NEAR THE TERMINAL AORTA WAS NARROW AND THE CONTRALATERAL LIMB SIDE (RIGHT) WAS SHAPED LIKE A CRESCENT MOON. FROM THESE OBSERVATIONS, IT WAS SUSPECTED THAT THE OCCLUSION OCCURRED IN THIS AREA. THE DOCTOR IS CONSIDERING EITHER BMS IMPLANTATION AFTER THROMBECTOMY OR F-F BYPASS PROCEDURE. THE PHYSICIAN STATED THAT AFTER THOROUGH OBSERVATION OF THE CT IMAGES, IT WAS PROBABLY NOT SUITABLE FOR THE PATIENT HAVING A NARROW LUMEN WITH 18MM OR LESS. THE PHYSICIAN BELIEVES THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT¿S TERMINAL AORTA, WHICH WAS JUST 18MM IN DIAMETER AND TOO NARROW TO ACCOMMODATE THE DEVICE. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610657 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04652587

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR