BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1101666 · Received August 7, 2008

    Report

    Report Number
    2953200-2008-00660
    Event Type
    Death
    Date Received
    August 7, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF POLYTRAUMATIC INJURIES, INCLUDING A CONTAINED AORTIC RUPTURE INDUCED BY THORACIC BLUNT TRAUMA. THIS EVENT WAS REPORTED IN THE JOURNAL OF VASCULAR SURGERY 2008; 47: 1195-1202, JUNE 2008. THE STENT GRAFTS WERE IMPLANTED BETWEEN 2001 AND 2007. IT WAS REPORTED THE PT PRESENTED WITH POLYTRAUMATIC INJURIES, INCLUDING A CONTAINED AORTIC RUPTURE INDUCED BY THORACIC BLUNT TRAUMA. AFTER INITIAL SUCCESSFUL ENDOVASCULAR REPAIR, THE PT UNDERWENT EMERGENCY CONVERSION BECAUSE OF DELAYED RUPTURE 31 DAYS LATER. IT WAS ALSO REPORTED THAT A CT SCAN CONFIRMED DEVICE MIGRATION. THE PT WAS TREATED BY AN EMERGENCY PROCEDURE INVOLVING HEMI ARCH AND DESCENDING AORTIC REPLACEMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT HAD EXPIRED.

    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 40 YR Death| R