BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2133356 · Received June 14, 2011

    Report

    Report Number
    2953200-2011-01141
    Event Type
    Death
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEATH, OCCLUSION), (MODERATE AMOUNT OF THROMBUS, NARROW ILIAC VESSELS). CONCLUSIONS: (MODERATE AMOUNT OF THROMBUS, NARROW ILIAC VESSELS).

    Description of Event or Problem · 1

    A TALENT CAPTIVIA THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 6 CM IN DIAMETER THORACIC AORTIC ANEURYSM EXTENDING FROM APPROX 2 CM DISTAL TO THE LEFT SUBCLAVIAN TO THE CELIAC ARTERY APPROX ONE MONTH AGO. THE VESSEL MORPHOLOGY WAS REPORTED AS THE AORTA HAD A STEEP ARCH, AND THE AORTIC NECK WAS 35-36 MM IN DIAMETER. THERE WAS A MODERATE AMOUNT OF THROMBUS THROUGHOUT THE AORTA. ILIACS WERE 6.5 MM IN DIAMETER W/O CALCIFICATION OR TORTUOSITY. THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED VIA THE LEFT SIDE, WHICH WAS THE BETTER OF THE TWO ILIACS. DUE TO THE NARROW ILIAC DIAMETER, THE 24 FR TALENT CAPTIVIA DEVICE (REF MFR# 2953200-2011-01140) HAD A LITTLE RESISTANCE WHEN BEING ADVANCED. HOWEVER, THE DEVICE WAS ABLE TO BE DELIVERED TO THE INTENDED LANDING ZONE W/O KINKING. THE 25 FR DISTAL TALENT DEVICE (REF MFR #2953200-2011-01141) COULD NOT BE ADVANCED AT ALL BUT DID NOT KINK. A RETROPERITONEAL INCISION AND CONDUIT WERE THEN USED, AND THE DISTAL MAIN WAS THEN DELIVERED AND DEPLOYED W/O ISSUES. LATER THE EVENING, THE PT HAD A LARGE LEFT FRONTAL CEREBRAL INFARCTION. A RADIOLOGIST COMMENTED THAT THERE MIGHT HAVE BEEN EMBOLI GOING UP THE LEFT CAROTID ARTERY. IT WAS REPORTED THAT THE NINE DAYS POST STENT GRAFT IMPLANT, THE PT EXPIRED DUE TO A LARGE CEREBRAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00505538

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R