BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 4260222 · Received November 18, 2014

    Report

    Report Number
    2953200-2014-02425
    Event Type
    Injury
    Date Received
    November 18, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 10, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT AAA STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 70 CM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT CAME IN FOR ROUTINE CT FOR SURVEILLANCE POST ENDOVASCULAR ANEURYSM REPAIR (EVAR) AND IT WAS DISCOVERED THAT A PREVIOUSLY IMPLANTED STENT GRAFT HAD MIGRATED AND HAD A TYPE IA ENDOLEAK INTO AN ENLARGED AORTIC ABDOMINAL ANEURYSM. A CUFF WAS SUCCESSFULLY PLACED TO SEAL OFF THE TYPE IA ENDOLEAK AND THE ISSUE RESOLVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ROOT CAUSE OF THE MIGRATION AND TYPE IA ENDOLEAK WAS DISEASE PROGRESSION. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746821 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention