BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT WITH XCELERANT

    MDR report key: 2161863 · Received July 8, 2011

    Report

    Report Number
    2953200-2011-01257
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ENDOLEAK, DISEASE PROGRESSION AND/OR DILATATION OF THE DISTAL AORTIC NECK. EVALUATION, CONCLUSION: DISEASE PROGRESSION AND/OR DILATATION OF THE DISTAL AORTIC NECK.

    Description of Event or Problem · 1

    THREE TALENT THORACIC STENT GRAFTS WERE IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM, APPROXIMATELY SEVEN MONTHS AGO WITHOUT ISSUES. A ROUTINE CT LAST MONTH SHOWED THAT A DISTAL TYPE I ENDOLEAK WITH POSSIBLE ANEURYSMAL DISEASE PROGRESSION AND/OR DILATATION OF THE DISTAL AORTIC NECK. AN INTERVENTION OCCURRED ONE MONTH AGO WITH TWO ADDITIONAL STENT GRAFTS; A TALENT DISTAL MAIN STENT GRAFT WAS PLACED DISTALLY; AND A TALENT CAPTIVIA STENT GRAFT WAS PLACED TO OVERLAP THE NEW TALENT DISTAL MAIN STENT GRAFT AND THE ORIGINAL TALENT DISTAL STENT GRAFT. 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 WITH XCELERANT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00480645

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention