BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1772399 · Received July 23, 2010

    Report

    Report Number
    2953200-2010-01396
    Event Type
    Injury
    Date Received
    July 23, 2010
    Date of Event
    June 24, 2010
    Report Date
    June 24, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    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: (DISSECTION, ARTERIAL AND VESSEL OCCLUSION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8 CM THORACIC AORTIC ANEURYSM. THE AORTA WAS VERY TORTUOUS. ILIAC VESSEL MORPHOLOGY WAS NOT REPORTED. IT WAS REPORTED THAT AFTER IMPLANTING THE TALENT THORACIC STENT GRAFT, A CHANGE IN THE PATIENT'S BLOOD PRESSURE WAS NOTICED; A DISSECTION IN THE GROIN WAS EVIDENT AFTER THE REMOVAL OF THE DELIVERY CATHETER. IN ADDITION, AN OCCLUSION IN THE ILIAC VESSEL WAS NOTED. THE PHYSICIAN ELECTED TO INTERVENE WITH A FOGARTY CATHETER TO REMOVE THE CLOT AND ALSO PLACED AN 18 MM ANEURX LIMB. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00214394

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention