BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2063847 · Received April 15, 2011

    Report

    Report Number
    2953200-2011-00818
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    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: ENDOLEAK. LARGE DIAMETER AORTIC NECK. THORACIC STENT GRAFT IMPLANTED IN THE ABDOMINAL AORTA. CONCLUSION: LARGE DIAMETER AORTIC NECK. THORACIC STENT GRAFT IMPLANTED IN THE ABDOMINAL AORTA.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7 CM ABDOMINAL AORTIC ANEURYSM. THE VESSELS WERE MODERATELY CALCIFIED AND MODERATELY TORTUOUS. THE AORTIC NECK WAS LARGE IN DIAMETER. THE PATIENT WAS SEVERELY OBESE OVER (B)(6) AND WAS NOT AN OPEN SURGICAL REPAIR CANDIDATE. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT WAS INTENTIONALLY IMPLANTED LOW IN THE AORTIC NECK FOLLOWED BY THE IMPLANT OF A 46 MM TALENT THORACIC STENT GRAFT WHICH WAS IMPLANTED PROXIMAL TO THE BIFURCATED STENT GRAFT. THE FINAL ANGIOGRAM REVEALED THAT THERE WAS A TYPE III ENDOLEAK BETWEEN THE BIFURCATED STENT GRAFT AND THE THORACIC STENT GRAFT (SEE MFR REPORT # 2953200-2011-00817). AN ADDITIONAL 46 MM THORACIC STENT GRAFT WAS IMPLANTED AND THE TYPE III ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00517247

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention