BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2922646 · Received January 18, 2013

    Report

    Report Number
    2953200-2013-00124
    Event Type
    Death
    Date Received
    January 18, 2013
    Date of Event
    November 30, 2009
    Report Date
    December 20, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ANEURYSM ENLARGEMENT). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TYPE II ENDOLEAK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TYPE II ENDOLEAK).

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (INSUFFICIENT INFORMATION; CAUSE OF DEATH IS UNKNOWN). CONCLUSIONS: (INSUFFICIENT INFORMATION; CAUSE OF DEATH IS UNKNOWN).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF DEATH WAS REPORTED TO BE FAILURE TO THRIVE.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.6 CM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 38 MONTHS AGO. THE PROXIMAL AORTA WAS 20 MM IN DIAMETER AND 12 MM IN LENGTH. THE DISTAL AORTA WAS 22 MM IN DIAMETER. THE RIGHT ILIAC ARTERY WAS 12 MM IN DIAMETER AND THE LEFT WAS 19 MM. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 11 AND 10 MM IN DIAMETER RESPECTIVELY. TORTUOSITY OF THE ILIAC ARTERIES WAS MILD BILATERALLY. A TALENT BIFURCATED STENT GRAFT AF2414C140XH WAS IMPLANTED ON THE RIGHT SIDE, AN ILIAC IW1414C105XH AND AN IW1414C75XH WERE IMPLANTED FROM THE LEFT SIDE. APPROXIMATELY THREE WEEKS POST IMPLANT THE ANEURYSM DIAMETER WAS 6.8 CM. AT THE ONE YEAR FOLLOW-UP THE ANEURYSM DIAMETER WAS 7.0 CM AND IT WAS 7.3 CM AT THE TWO YEAR FOLLOW-UP. THE MOST RECENT MEASUREMENT APPROXIMATELY SEVEN MONTHS AGO THE ANEURYSM DIAMETER WAS 7.1 CM. A TYPE II ENDOLEAK WAS REPORTED AT EACH FOLLOW-UP VISIT, WHICH WAS COILED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT PRESENTED TO A HOSPITAL OUTSIDE THE USA WITH A FEVER AND DANGEROUSLY LOW HEMOGLOBIN. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION, BUT NO ADDITIONAL ACTIONS WERE TAKEN. A DNR ORDER WAS IN PLACE, AND THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE PATIENT WAS REPORTED TO BE VERY FRAIL AND EMACIATED. THE PATIENT WAS BARELY EATING AND HADN'T SPOKEN IN APPROXIMATELY A YEAR. THE PATIENT WAS MUCH DEBILITATED WITH BINSWANGER'S DISEASE, BUT WAS NOT BEING ROUTINELY FOLLOWED BY A PHYSICIAN. THE INVESTIGATOR STATED THAT THE DEATH WAS VERY LIKELY NOT DEVICE OR ANEURYSM RELATED, HOWEVER THIS CANNOT BE CONFIRMED. ADDITIONAL INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27860 TALENT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00263157

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Death| R