BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1111732 · Received August 14, 2008

    Report

    Report Number
    2953200-2008-00677
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (INFECTION); LACK OF INFO (UNK CAUSE OF INFECTION). CONCLUSION: LACK OF INFO (UNK CAUSE OF INFECTION). MEDICAL INTERVENTION REQUIRED (HOSPITALIZATION AND ANTIBIOTICS). - (INFECTION).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.0 X 5.9 CM DESCENDING THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROX 52 MONTHS POST STENT GRAFT IMPLANT THERE WERE MULTIPLE POCKETS OF GAS WITHIN THE THORACIC AORTIC LUMEN SURROUNDING THE STENT GRAFT. ADD'L POCKETS OF GAS WERE WITHIN THE THROMBUS OF THE ABDOMINAL AORTIC ANEURYSM AND WITHIN THE SUPRARENAL AORTIC THROMBUS. THERE WAS ALSO RETROPERITONEAL PARA-AORTIC INFLAMMATORY STRANDING. THESE FINDINGS ARE MOST CONSISTENT WITH INFECTIOUS AORTITIS ACCORDING TO THE OPERATIVE REPORTS. IT WAS REPORTED THAT THERE WAS THROMBUS WITHIN THE ABDOMINAL AORTA, INCLUDING WITHIN A 4.6 AM INFRARENAL AORTIC ANEURYSM. THERE IS EXTENSIVE ATHEROSCLEROTIC CALCIFICATION OF THE AORTA, ILIAC ARTERIES, AND THE MAJOR ABDOMINAL ARTERIES. THE PT WAS TREATED WITH ANTIBIOTICS. IT IS POSSIBLE THAT THE CAUSE OF THE PATHOGEN MAY BE RELATED TO THE BOWEL ACCORDING TO THE OPERATIVE REPORTS. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 34687

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R