BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2003572 · Received February 23, 2011

    Report

    Report Number
    2953200-2011-00490
    Event Type
    Death
    Date Received
    February 23, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - (DEATH, ENDOLEAK, PERFORATION, OCCLUSION). (SEVERELY CALCIFIED AND NARROW ACCESS VESSELS). CONCLUSIONS: (SEVERELY CALCIFIED AND NARROW ACCESS VESSELS).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A FUSIFORM IN SHAPE MEASURING 5.6 CM DIAMETER THORACIC AORTIC ANEURYSM. ONE MONTH PRIOR TO THE ENDOVASCULAR PROCEDURE, THE LEFT SUBCLAVIAN WAS TRANSPOSITIONED AND A CAROTID TO SUBCLAVIAN BYPASS WAS PERFORMED. THE THORACIC NECK DIAMETER IS 31 MM 2 CM PROXIMAL TO THE ANEURYSM AND IMMEDIATELY PROXIMAL TO THE ANEURYSM IT IS 30 MM. DISTAL TO THE ANEURYSM THE AORTA IS 35 MM AND 2 CM DISTAL TO THE ANEURYSM IT IS 30 MM. THE RIGHT EXTERNAL ILIAC IS 6.5 MM AND THE LEFT IS 7 MM IN DIAMETER. THE FEMORAL ARTERIES ARE 7 MM AND THE COMMON ILIAC ARE 12 MM BILATERALLY IN DIAMETER. THE ACCESS ARTERY IS SEVERELY CALCIFIED. THE INTENDED INTRODUCTION SITE IS THE RIGHT FEMORAL ARTERY. IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE STENT GRAFT THE DELIVERY SYSTEM GOT STUCK IN THE ILIAC ARTERY WITH THE NOSE CONE IN THE MIDDLE OF THE AORTA DUE TO THE DAMAGE FROM MULTIPLE DELIVERY SYSTEMS BEING PASSED THROUGH THE VESSEL. THE PHYSICIAN CUT THE DELIVERY CATHETER, REMOVED A SECTION OF ILIAC ARTERY AND PERFORMED A FEM-FEM BYPASS WITH ANOTHER MANUFACTURER'S GRAFT. IT WAS REPORTED THAT THERE WAS A DISTAL TYPE I ENDOLEAK THAT WAS REPAIRED WITH AN UNKNOWN CUFF. A TALENT CONVERTER STENT GRAFT WAS IMPLANTED IN THE ABDOMINAL AORTIC ARTERY TO CHANNEL BLOOD FLOW TO THE RIGHT LEG. THERE WAS 6,000ML BLOOD LOSS IN WHICH THERE WERE 2 UNITS OF BLOOD TRANSFUSED. THE INVESTIGATOR ASSESSED THIS ADVERSE EVENT AS PROCEDURE AND DEVICE RELATED. IT WAS REPORTED THAT ONE MONTH POST STENT GRAFT IMPLANT THE PATIENT WAS PLACED ON A VENTILATOR AND THE PATIENT'S MENTAL STATUS HAD CHANGED. A BRAIN CT WAS PERFORMED WITH NO ACUTE FINDINGS. THE INVESTIGATOR ASSESSED THAT BOTH EVENTS WERE NOT RELATED TO THE STUDY DEVICE BUT WERE RELATED TO THE STUDY PROCEDURE. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR A FEMORAL-POPLITEAL BYPASS AND IT WAS BELIEVED THAT THE ARTERIAL OCCLUSION WAS RESOLVED. PATIENT HAD MULTI-ORGAN FAILURE TWO DAYS LATER AND THE PATIENT EXPIRED. THE INVESTIGATOR IS UNABLE TO DETERMINE IF THE CAUSE OF DEATH BUT HAS ASSESSED THAT IT WAS RELATED TO THE STUDY PROCEDURE. (REF MFR# 2953200-2011-00491 AND 2953200-2011-00492).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00487552

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death