BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1163587 · Received September 17, 2008

    Report

    Report Number
    2953200-2008-00817
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (REQUIRED SECONDARY INTERVENTION).

    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 62 MM IN DIAMETER AT THE TIME OF IMPLANT. THE AORTIC NECK WAS REVERSE FUNNEL SHAPED; IT WAS 26 MM IN DIAMETER BELOW THE RENAL ARTERIES AND 15 MM DISTAL TO THAT IT WAS 32 MM. THE STENT GRAFT WAS PLACED 1 MM BELOW THE RENAL ARTERIES WITH A 14 MM SEAL ZONE. THERE WAS 30 MM OF ILIAC FIXATION BILATERALLY AND 5 MM DISTANCE BETWEEN THE STENT GRAFT AND THE HYPOGASTRIC ARTERIES BILATERALLY. IT WAS REPORTED THAT THE STENT GRAFT MIGRATED 20 MM 1 YEAR POST IMPLANT AND THE ANEURYSM MEASURED 62 MM IN DIAMETER WITH NO ENDOLEAK PRESENT. THE PT WAS TREATED WITH AN AORTO-UNI-ILIAC DEVICE. IT WAS REPORTED THAT AFTER THE AORTO-UNI-ILIAC DEVICE WAS IMPLANTED, THE DELIVERY SYSTEM WAS REMOVED; HOWEVER, A SMALL PIECE OF BODY TISSUE CAME OUT WITH THE DELIVERY SYSTEM. NO ADD'L INFO WAS PROVIDED AND THAT PT WAS REPORTED TO BE IN GOOD CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention