BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2798048 · Received October 22, 2012

    Report

    Report Number
    2953200-2012-02006
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 23, 2012
    Report Date
    September 23, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (STENT GRAFT MIGRATION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED; DISEASE PROGRESSION). EVALUATION, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED; DISEASE PROGRESSION).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY FOUR YEARS AGO. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WAS NOT REPORTED. THE TALENT BIFURCATED STENT GRAFT WAS 2 CM BELOW THE RIGHT RENAL, WITH NO PURCHASE. THE AORTA APPEARED VERY DISEASED AND MEASURED ABOUT 30MM IN DIAMETER FOR APPROXIMATELY 12-15MM. HOWEVER, THERE WAS A HUGE THROMBUS BURDEN ON THE LEFT WALL WITHOUT AN ENDOLEAK PRESENT. THE ANEURYSM WAS NOW 7 CM IN DIAMETER. ALSO, THE RIGHT ILIAC LIMB WAS BARELY IN THE RIGHT COMMON AND THERE WAS NO SEAL THERE EITHER (IPSILATERAL WAS ON THE RIGHT). A TALENT THORACIC STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF PENETRATING ULCERS APPROXIMATELY ONE MONTH AGO WITHOUT ISSUES. AFTER FIXING THE THORACIC PENETRATING ULCERS, WHICH WERE THE CAUSE OF THE PATIENT'S ADMISSION, A 3636X70 ENDURANT CUFF WAS IMPLANTED IN THE INFRARENAL NECK, AND A 161393 LIMB WAS IMPLANTED IN THE RIGHT COMMON, EXTENDING INTO THE EXTERNAL ILIAC. THE STENT GRAFT MIGRATION WAS RESOLVED. 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 SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00183247

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention