BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 3232889 · Received July 18, 2013

    Report

    Report Number
    2953200-2013-01382
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT MIGRATION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION, NECK DILATATION). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION, NECK DILATATION).

    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 AT THE TIME OF IMPLANT IS UNKNOWN. DURING A FOLLOW UP VISIT IT WAS DETERMINED THAT THE TALENT STENT GRAFT HAD MIGRATED DISTALLY DUE TO DISEASE PROGRESSION AND NECK DILATATION. THE PHYSICIAN FOUND NO SIGNS OF ENDOLEAK. AN ENDURANT CUFF WAS ADDED AND THE INTERVENTION WAS COMPLETED SUCCESSFULLY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334206 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00413084

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention