BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1471071 · Received September 11, 2009

    Report

    Report Number
    2953200-2009-01277
    Event Type
    Injury
    Date Received
    September 11, 2009
    Date of Event
    August 13, 2009
    Report Date
    August 13, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: (ENDOLEAK), (ANEURYSM ENLARGEMENT), (IDENTITY OF WHICH DEVICES SEPARATED NOT REPORTED). CONCLUSION: (ANEURYSM ENLARGEMENT), (IDENTITY OF WHICH DEVICES SEPARATED NOT REPORTED). (INTERVENTION REQUIRED).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROX 11 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. A TOTAL OF 5 TALENT THORACIC GRAFTS WERE IMPLANTED WITHOUT ISSUES. IT WAS REPORTED THAT THERE HAS BEEN NOTED ANEURYSM SAC GROWTH OF ABOUT 0.75 CM. CONSEQUENTLY, THERE IS NOW A TYPE III SEPARATION ENDOLEAK BETWEEN 2 OF THE TALENT STENT GRAFTS (MDR 2952300-2009-01278), DUE TO THE SAC ENLARGEMENT AND REMODELING OF THE DEVICES. THE PHYSICIAN HAS ELECTED TO INTERVENE FOR THE ENDOLEAK AT A LATER DATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention