BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1081363 · Received July 24, 2008

    Report

    Report Number
    2953200-2008-00594
    Event Type
    Death
    Date Received
    July 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    TALENT THORACIC STENT GRAFTS WERE IMPLANTED IN VARIOUS PATIENTS FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSMS. THE AUTHOR REPORTED THAT THERE WERE VARIOUS ADVERSE EVENTS THAT OCCURRED IN THE VALOR TRIAL LISTED IN JOURNAL ARTICLE: J VASC SURG 2008.03.061, PIVOTAL RESULTS OF THE MEDTRONIC VASCULAR THORACIC STENT GRAFT SYSTEM: THE VALOR TRIAL. IN TOTAL PATIENTS (99.5%) VESSEL ACCESS AND STENT GRAFT DEPLOYMENT WERE SUCCESSFUL AT THE INTENDED SITE. THE 30 DAY VALOR RESULTS INCLUDED PERIOPERATIVE MORTALITY, 2.1%, MAJOR ADVERSE EVENTS, 41%; INCIDENT OF PARAPLEGIA, 1.5%; PARAPARESIS, 7.2%; AND STROKE, 3.6%. THE 12 MONTH VALOR RESULTS INCLUDED ALL CAUSE MORTALITY, 16.1%; ANEURYSM-RELATED MORTALITY, 3.1%; CONVERSION TO OPEN SURGERY, 0.5%; TARGET ANEURYSM RUPTURE, 0.5%; STENT GRAFT MIGRATION >10MM, 3.9%; ENDOLEAK (12.2%) STABLE OR DECREASING ANEURYSM DIAMETER, 91.5%; STENT PATENCY, 100%; AND LOSS OF STENT GRAFT INTEGRITY, FOUR PATIENTS. NO DEPLOYMENT RELATED EVENTS OR PERFORATION OF THE AORTA BY A GRAFT COMPONENT OCCURRED. PLEASE NOTE THE JOURNAL ARTICLE WAS SUBMITTED TO THE PUBLISHER ON DECEMBER 3, 2007 PRIOR PMA APPROVAL OF THE TALENT THORACIC STENT GRAFT SYSTEM IN THE U.S. ON 06/5/2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| R