BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2063844 · Received April 15, 2011

    Report

    Report Number
    2953200-2011-00821
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS, CONCLUSION: DISEASE PROGRESSION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROXIMATELY 20 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNKNOWN. CURRENTLY THE ANEURYSM SIZE WAS NOTED TO BE SAME AS THE TIME OF IMPLANT. THE VESSELS HAD MILD CALCIFICATION AND MODERATE TORTUOSITY. IT WAS REPORTED THAT A RECENT CT SCAN DEMONSTRATED THAT THERE IS A NEW ANEURYSM DISTAL TO THE MOST DISTAL STENT GRAFT WHICH THE PHYSICIAN ATTRIBUTED TO CONTINUED DISEASE PROGRESSION. TWO ADDITIONAL STENT GRAFTS WERE IMPLANTED DISTALLY TO ADDRESS THE DISEASE PROGRESSION RELATED ANEURYSM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00173683

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention