BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4133503 · Received October 1, 2014

    Report

    Report Number
    2953200-2014-01966
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A ROUTINE ANNUAL FOLLOW UP VISIT. THE PATIENT WAS ASYMPTOMATIC. DISTAL TYPE I ENDOLEAKS WERE SEEN IN BOTH ILIAC ARTERIES, AT THE DISTAL ENDS OF BOTH THE BIFURCATE AND THE CONTRALATERAL LIMB. THE PHYSICIAN STATED THAT THE ENDOLEAKS WERE DUE TO ARTERY DILATATION. BOTH ILIAC ARTERIES WERE EXTENDED WITH FLARED LIMB GRAFTS, AND THE ENDOLEAKS WERE RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613269 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention