BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT

    MDR report key: 3961389 · Received July 28, 2014

    Report

    Report Number
    2953200-2014-01469
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE TALENT BIFURCATE HAS MIGRATED APPROXIMATELY 4-5CM AND IS IN THE ANEURYSM SAC. A PROXIMAL TYPE I ENDOLEAK WAS ALSO OBSERVED. THE PHYSICIAN SUSPECTS THE CAUSE OF THE EVENT WAS MOST LIKELY DUE TO DISEASE PROGRESSION; NECK DILATATION. THE PHYSICIAN INTERVENED AND REALIGNED THE TALENT STENT GRAFT WITH AN ENDURANT BIFURCATE AND CONTRALATERAL LIMBS RESOLVING THE ENDOLEAK. THERE WERE NO ISSUES DURING THE INTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437387 TALENT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00176006

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention