BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT XCELERANT STENT GRAFT WITH HYDRO

    MDR report key: 2160764 · Received July 7, 2011

    Report

    Report Number
    2953200-2011-01250
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    February 2, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: ENDOLEAK, AORTIC ANGULATION NEAR THE ENDOLEAK AREA. EVALUATION, CONCLUSION: AORTIC ANGULATION NEAR THE ENDOLEAK AREA.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM, APPROXIMATELY 4 YEARS AGO. A CT WAS PERFORMED FIVE MONTHS AGO WHICH SHOWED ANEURYSM GROWTH, AN UNK ENDOLEAK, ALONG WITH THE PROXIMAL APEX OF THE STENT GRAFT BEING SEPARATED FROM THE GRAFT MATERIAL. THE ENDOLEAK WAS TREATED AS A TYPE I ENDOLEAK, BUT THE PHYSICIAN BELIEVES THERE IS A TYPE II ENDOLEAK. THERE HAS BEEN NO FURTHER INTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. AN INTERNAL FILM REVIEW SHOWED THAT THE SUPRARENAL STENT APPEARS TO BE PARTIALLY DETACHED FROM THE GRAFT MATERIAL. THERE ALSO APPEARS TO BE A TYPE III ENDOLEAK WITH BLOOD GLOW PROTRUDING FROM THE GRAFT BODY INTO THE ANEURYSM SAC. IT IS POSSIBLE THERE IS MORE THAN ONE AREA ON THE BACK OF THE GRAFT THAT IS ALLOWING BLOOD TO ESCAPE. IT IS HARD TO DETERMINE FROM THE STATIC SCAN WHERE THE ORIGIN IS AND WHERE BLOOD IS COLLECTING NEXT TO THE GRAFT. THERE DOES NOT APPEAR TO BE ANY STENT BREAKAGE THAT COULD BE A CONTRIBUTING FACTOR TO A LEAK IN THE GRAFT MATERIAL. ANOTHER OBSERVATION IS THAT THE STENT GRAFT IS IN A FAIRLY AGGRESSIVE ANGULATION, FRONT-TO-BACK, RESULTING IN AN ARCH IN THE GRAFT BODY NEAR THE LEAK AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT XCELERANT STENT GRAFT WITH HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00008610

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention