BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 3971758 · Received July 31, 2014

    Report

    Report Number
    2953200-2014-01495
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. IT WAS REPORTED THAT THE PATIENT WAS IN FOR THEIR FOUR YEAR ROUTINE FOLLOW UP. IT WAS NOTED THAT THE COMMON ILIAC WAS 1.8 CM AND THAT THERE WAS A TYPE IB ENDOLEAK. THE CAUSE OF THE ENDOLEAK WAS DISEASE PROGRESSION OF THE RIGHT COMMON ILIAC. TWO ENDURANT II LIMBS 16X13X156, 16X16X124 WERE IMPLANTED AND THE ENDOLEAK RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448933 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention