BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1101770 · Received August 7, 2008

    Report

    Report Number
    2953200-2008-00657
    Event Type
    Injury
    Date Received
    August 7, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: (ARTERIAL TRAUMA/DISSECTION), (ACUTE TYPE B DISSECTION). CONCLUSION: (ACUTE TYPE B DISSECTION).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ACUTE RETROGRADE TYPE B DISSECTION. 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 REC'D A TALENT DEVICE TO TREAT AN ACUTE RETROGRADE TYPE B DISSECTION WITH MESENTERIC AND LEG ISCHEMIA. AN ACUTE RETROGRADE TYPE A DISSECTION WAS CAUSED 38 DAYS POST PROCEDURE BY AN INTIMAL TEAR INDUCED BY THE BARE SPRINGS OF THE ENDOGRAFT. THE PT WAS TREATED BY AN EMERGENCY PROCEDURE INVOLVING SUPRA-CORONARY ARCH REPLACEMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT WAS DISCHARGED.

    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 52 YR Required Intervention