BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM WITH XCELERANT

    MDR report key: 1870725 · Received October 8, 2010

    Report

    Report Number
    2953200-2010-01915
    Event Type
    Death
    Date Received
    October 8, 2010
    Date of Event
    July 24, 2010
    Report Date
    September 10, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: (ARTERIAL AND VENOUS OCCLUSION, DEATH).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE ENDOVASCULAR TREATMENT OF A 7.6CM THORACIC ANEURYSM APPROX THREE MONTHS AGO. THE EVENT WAS REPORTED FROM A CLINICAL REPORT FORM. THE ILIAC VESSELS HAD MODERATE CALCIFICATION AND NO TORTUOSITY. THE STENT GRAFT DELIVERY SYSTEM WAS ADVANCED THROUGH THE RIGHT FEMORAL ARTERY AND THE FIRST STENT GRAFT WAS IMPLANTED IN ZONE 3, THE SECOND AND THIRD DEVICES WERE IMPLANTED IN ZONE 4 WITHOUT ISSUE. IT WAS REPORTED THAT THE PT REMAINED IN THE HOSPITAL FOLLOWING THE STENT GRAFT PROCEDURE. THREE DAYS POST STENT GRAFT IMPLANT, THE ANEURYSM WAS COMPRESSING THE PT'S TRACHEA. THE PT WAS EXTUBATED, THEN BECAME PROGRESSIVELY MORE SOMNOLENT, INCUBATED EMERGENTLY FOR HYPERCAPNIC RESPIRATORY FAILURE AND WAS PUT ON DIALYSIS (FOR RENAL FAILURE). THE PT HAD A ACT WITH CONTRAST ONE MONTH A AGO REVEALING STENT GRAFT THROMBOSIS AND THE SIZE OF THE THORACIC ANEURYSM WAS 7.2 CM IN DIAMETER. THE PT WAS PUT ON DNR AND COMFORT MEASURES BY THE FAMILY. IT WAS REPORTED THAT THREE MONTHS POST STENT GRAFT IMPLANT, THE PT EXPIRED. THE INVESTIGATOR STATED THAT THE DEATH WAS NOT RELATED TO THE DEVICE OR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM WITH XCELERANT MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00479351

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death