BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4131402 · Received October 1, 2014

    Report

    Report Number
    2953200-2014-01954
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    May 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 4.7 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THERE WAS SEVERE CALCIFICATION IN THE AORTA AND ARTERIES. THE PATIENT PRESENTED WITH A COLD LEG. THE ANGIOGRAM REVEALED THAT THE CONTRALATERAL LIMB WAS OCCLUDED FROM THE FLOW DIVIDER DOWN. THE PHYSICIAN ELECTED TO USE LYSIS AND BALLOON WITH ANGIOPLASTY BALLOON THE ILIAC LIMBS. THE BLOOD FLOW WAS RESTORED. THE FOLLOW UP ANGIOGRAM REVEALED THAT THE STENT GRAFTS WAS STILL PATENT WITH GOOD BLOOD FLOW. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610632 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03018690

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention