BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA

    MDR report key: 3944220 · Received July 18, 2014

    Report

    Report Number
    2953200-2014-01409
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP AT FIVE YEARS POST IMPLANT THE ANEURYSM WAS 13 X 12 CM. THERE WAS A TYPE IA ENDOLEAK WITH PROGRESSIVE DILATION OF THE PROXIMAL AORTIC NECK WHICH WAS SEVERELY ANGULATED. THE BIFURCATED STENT GRAFT MIGRATED AND IT WAS 1CM DISTAL TO THE LOWEST RIGHT RENAL ARTERY DUE TO THE DILATION OF THE PROXIMAL AORTIC NECK. IT WAS ALSO REPORTED THAT THE RIGHT DISTAL COMMON ILIAC ARTERY CONTINUED TO DILATE AND THERE WAS A TYPE IB ENDOLEAK NOTED / SUSPECTED. ONE DAY LATER COIL EMBOLIZATION OF RIGHT HYPOGASTRIC ARTERY WAS PERFORMED AND 16/10/199 ENDURANT LIMB WAS IMPLANTED INTO THE EXTERNAL ILIAC ARTERY. A 36/36/70 ENDURANT CUFF WAS IMPLANTED PROXIMALLY TO ADDRESS THE MIGRATION AND THE TYPE IA ENDOLEAK. THE RIGHT RENAL ARTERY WAS PATENT AND THE LEFT WAS 99 % STENOSED AND THE LEFT KIDNEY IS HYPOPLASTIC. THE PROCEDURE WAS SUCCESSFUL AND THE ENDOLEAK RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422912 TALENT AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00117622N

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention