BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC - XCELERANT

    MDR report key: 2130030 · Received June 10, 2011

    Report

    Report Number
    2953200-2011-01110
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK), (SEVERE ANGULATION), (USE OF THORACIC DEVICE IN THE ABDOMINAL AORTA). EVAL, CONCLUSION: (SEVERE ANGULATION), (USE OF THORACIC DEVICE IN THE ABDOMINAL AORTA).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6.8 CM ABDOMINAL AORTIC ANEURYSM APPROX 10 MONTHS AGO. THE VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WAS REPORTED AS THE AORTIC NECK WAS SEVERELY ANGULATED AND 35 - 37 MM DIAMETER. ILIAC VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. A TALENT THORACIC CUFF WAS PLACED PROXIMALLY VIA THE RIGHT ILIAC AT THE TIME OF IMPLANT, BUT THE CUFF HAD LANDED VERY LOW ON THE RIGHT SIDE. NO INTERVENTION WAS PERFORMED AT THAT TIME. A RECENT ANGIOGRAM REVEALED A PROXIMAL TYPE I ENDOLEAK, AS THE TAA CUFF APPEARED TO BEING SITTING ANTERIORLY AND WAS APPROX 1 CM BELOW THE LOWEST LEFT RENAL AND APPROX 2 CM BELOW THE RIGHT RENAL. AS THE TALENT TAA CUFF WAS IMPLANTED LOW INITIALLY, THERE WAS NO MIGRATION. THE ENDOLEAK WAS INITIALLY THOUGHT TO BE TYPE II ENDOLEAK. CURRENTLY, THE PROXIMAL NECK WAS ANGLED APPROX 70 - 80 DEGREES, WHICH IS UNCHANGED SINCE THE IMPLANT, AND THE AORTIC NECK DILATED SLIGHTLY TO 39 - 41 MM IN DIAMETER. THERE HAS ALSO BEEN ANEURYSM SAC GROWTH FROM 6.8 CM TO 7.2 CM. ONE MONTH AGO AN ENDURANT CUFF WAS PLACED INSIDE THE BIFURCATED STENT GRAFT/TAA CUFF, AND A 44X44X54 TALENT TAA CUFF WAS PLACED PROXIMALLY VIA THE LEFT ILIAC WITH ADEQUATE OVERLAP AND LANDED RIGHT BELOW THE LOWEST LEFT RENAL AND A FEW MM BELOW THE RIGHT RENAL. THE ENDOLEAK WAS RESOLVED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC - XCELERANT MIH MEDTRONIC CARDIOVASCULAR NA V00248456

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention