BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2010911 · Received March 4, 2011

    Report

    Report Number
    2953200-2011-00602
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (GRAFT MIGRATION, ANEURYSM ENLARGEMENT); (UNK CAUSE OF STENT FRACTURE). CONCLUSION: (UNK CAUSE OF STENT GRAFT FRACTURE).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 7 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE STENT GRAFT SEEMS TO HAVE SLIPPED A LITTLE AND HAS DEVELOPED A STENT GRAFT FRACTURE. THERE IS NO EVIDENCE OF A TYPE 1 ENDOLEAK, BUT RECENTLY THERE HAS BEEN SIGNIFICANT SAC GROWTH NOTICED FROM THE PREVIOUS SCAN LAST YEAR TO THE CURRENT SCAN. NO INTERVENTION HAS BEEN REPORTED. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA M03H901337

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK