BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT

    MDR report key: 2181397 · Received July 21, 2011

    Report

    Report Number
    2953200-2011-01310
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (MIGRATION, ENDOLEAK). RESULTS AND CONCLUSIONS: (ANGULATED NECK).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM 16 MONTHS AGO. VESSEL MORPHOLOGY AT TIME OF IMPLANT WAS REPORTED AS THE AORTIC NECK HAD A 60 DEGREE ANGLE. IT WAS REPORTED THAT THERE WAS NO ENDOLEAK ON THE ANGIOGRAM TAKEN AFTER IMPLANT. IT WAS REPORTED THAT THE PATIENT WAS SEEN FOR A ROUTINE FOLLOW-UP, ONE MONTH AGO, AND THE STENT GRAFT HAD MIGRATED 1 TO 1.5 CM DISTALLY RESULTING IN A PROXIMAL TYPE 1 ENDOLEAK. THE MIGRATION WAS ATTRIBUTED TO THE NECK ANGULATION. THE PATIENT WAS TREATED WITH TWO ENDURANT CUFFS THREE WEEKS LATER. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IF FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00431067

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention