BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT- HYDRO

    MDR report key: 1910539 · Received November 19, 2010

    Report

    Report Number
    2953200-2010-02285
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    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). EVALUATION, RESULTS: ENDOLEAK, PSEUDOANEURYSM ABOVE THE STENT GRAFT. CONCLUSIONS: PSEUDOANEURYSM ABOVE THE STENT GRAFT.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 26 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT DEVELOPED A PSEUDOANEURYSM ABOVE THE STENT GRAFT WHICH RESULTED IN AN ENDOLEAK AT THE LOCATION OF THE RENAL ARTERIES. THE EXPLANTED STENT GRAFT WAS MANGLED, CUT UP AND DISCARDED BY THE USER FACILITY. THE PHYSICIAN CUT THE BIFURCATED GRAFT IN HALF AND SUTURED A TUBE GRAFT TO THE EXISTING GRAFT SO THE ILIAC LIMBS COULD REMAIN IN THE PATIENT. IT WAS REPORTED THAT RECENTLY A RENAL TO HEPATIC BYPASS PROCEDURE WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention