BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3964844 · Received July 29, 2014

    Report

    Report Number
    2953200-2014-01476
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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. THE PROXIMAL NECK WAS 23-25 MM IN DIAMETER AND 15 MM IN LENGTH. THE LEFT COMMON ILIAC ARTERY WAS 12-13-11 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 10-16-10 MM IN DIAMETER. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, ON THE FINAL ANGIOGRAM RUN, AT PROXIMAL TYPE I ENDOLEAK WAS OBSERVED. AFTER REPEATED BALLOONING OF THE PROXIMAL EDGE OF THE MAIN BODY FOUR TIMES, THE ENDOLEAK COULD NOT BE RESOLVED. THE PHYSICIAN DECIDED TO IMPLANT ANOTHER MANUFACTURER¿S STENT TO REPAIR THE ENDOLEAK. THE STENT WAS PLACED PERFECTLY AND WITHOUT ISSUE. AFTER PLACEMENT ANOTHER COMPLETION ANGIOGRAM SHOWED THE ENDOLEAK WAS RESOLVED, AND THE CASE WAS COMPLETED. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441867 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04225285

    Patients

    Seq Age Sex Outcome Treatment
    1 00088 YR Required Intervention