BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1894922 · Received November 5, 2010

    Report

    Report Number
    2953200-2010-02163
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: ARTERIAL AND VENOUS OCCLUSION - UNK CAUSE OF PARTIAL RENAL OCCLUSION. CONCLUSION: UNK CAUSE OF PARTIAL RENAL OCCLUSION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 11 MONTHS AGO. THE AORTIC NECK WAS NOT CALCIFIED AND THE REMAINDER OF THE ANATOMY WAS UNREMARKABLE. IT WAS REPORTED THAT AT THE TIME OF IMPLANT THERE WAS FLOW TO BOTH RENAL ARTERIES AND THE PT WAS FINE. THE PT RETURNED FOR A ROUTINE F/U AND THE CT DEMONSTRATED THAT THERE WAS PARTIAL RENAL OCCLUSION AS FLOW APPEARS TO BE COMPROMISED TO RIGHT RENAL ARTERY. ACCORDING TO THE RADIOLOGIST THE RIGHT KIDNEY IS SHRINKING. THE PT IS ASYMPTOMATIC, CREATININE IS NORMAL, AND IS NOT HYPERTENSIVE. THERE HAS BEEN NO INTERVENTION, HOWEVER THE PHYSICIAN WILL CONTINUE TO MONITOR THE PT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA NA V00233349

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR