BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1192572 · Received October 8, 2008

    Report

    Report Number
    2953200-2008-00910
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ENDOLEAK. EXCESSIVE INFLATION OF THE BALLOON. CONCLUSIONS: EXCESSIVE INFLATION OF THE BALLOON.

    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 MORPHOLOGY, AT THE TIME OF IMPLANT, WAS NOT REPORTED. THE VESSEL WAS 10-11 MM IN DIAMETER, MILD TORTUOSITY AND MILD CALCIFICATION. IT WAS REPORTED THAT THERE WAS A TYPE III ENDOLEAK AND A TYPE II ENDOLEAK. THE PHYSICIAN BELIEVES THAT IT MAY BE A SUTURE POP OR A FABRIC TEAR. HOWEVER, THE PHYSICIAN STATED THAT THERE MAY HAVE BEEN EXCESSIVE INFLATION OF THE BALLOON WITH IN THE STENT GRAFT. THE PHYSICIAN ELECTED TO RELINE THE IPSILATERAL LIMB OF THE BIFURCATED STENT GRAFT WITH TWO AORTIC CUFF STENT GRAFTS AND THE ENDOLEAKS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00118500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention