BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1901567 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02217
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: (ENDOLEAK, MI), (MODERATELY CALCIFIED AND TORTUOUS VESSELS).

    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. THE ANEURYSM WAS OVER 5 CM IN DIAMETER AND THE VESSELS WERE MODERATELY TORTUOUS WITH MODERATE CALCIFICATION. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE DELIVERY SYSTEM BILATERALLY AND THE LEFT COMMON ILIAC RUPTURED AFTER 2 ATTEMPTS TO ADVANCE THE DELIVERY SYSTEM (MFR2953200-2010-02216). A 14X14X80 TALENT EXTENSION WAS USED TO COVER THE RUPTURE, BUT THERE WAS A TYPE 4 ENDOLEAK (MFR2953200-2010-02217). THE STENT GRAFT WAS RELINED WITH A 14X16X75 AND THE TYPE 4 ENDOLEAK RESOLVED. THE PHYSICIAN THEN TRIED THE MAIN BIFURCATED DELIVERY SYSTEM ON THE RIGHT SIDE AND IT WOULD NOT ADVANCED, SO HE CHOSE NOT TO CONTINUE WITH THE CASE. WHEN CLOSING THE PT, THE ILIAC WAS BLEEDING AND DUE TO LOSS OF BLOOD VOLUME, THE PT HAD AN MI AND CODED IN OPERATING ROOM. PT LEFT THE OPERATING ROOM IN STABLE CONDITION. THE PT IS REPORTED TO BE FINE. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00207915

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention