BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 3881518 · Received June 18, 2014

    Report

    Report Number
    2953200-2014-01214
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    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

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT WAS IN FOR A ROUTINE FOLLOW UP. A CT NOTED THAT THE DEVICE HAS MIGRATED RESULTING IN A TYPE I ENDOLEAK. THE ANEURYSM HAS GONE FROM 5 CM TO 5.5 CM IN DIAMETER. THE DEVICE MIGRATED 4.5 CM. THE CAUSE OF THE MIGRATION IS DUE TO NECK REMODELING. THE PHYSICIAN TREATED THE PATIENT WITH TWO ENDURANT STENT GRAFTS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357447 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00381462

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Required Intervention