BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3932998 · Received July 14, 2014

    Report

    Report Number
    2953200-2014-01388
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE INDEX PROCEDURE IS UNKNOWN. CURRENTLY, THE ANEURYSM IS 5.5CM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A ROUTINE FOLLOW UP AND A TYPE I ENDOLEAK WAS NOTED. THE PATIENT WAS COMPLIANT WITH REGULAR FOLLOW UP APPOINTMENTS. THE PATIENT WAS SUCCESSFULLY TREATED WITH A 25X25X49 AND THE ENDOLEAK RESOLVED. THE PHYSICIAN STATED THE CAUSE OF THE TYPE I ENDOLEAK WAS DISEASE PROGRESSION. A TYPE IV ENDOLEAK, BLUSH WAS NOTED AT THE FLOW DIVIDER. NO FURTHER INTERVENTION WAS DONE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410692 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01699878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention