BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT XCELERANT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1244655 · Received November 26, 2008

    Report

    Report Number
    2953200-2008-01105
    Event Type
    Death
    Date Received
    November 26, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 31, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (DEATH). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (COMPLEX PROCEDURE REQUIRING DE-BRANCHING OF THE INNOMINATE AND THE RIGHT COMMON CAROTID ARTERIES). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (COMPLEX PROCEDURE REQUIRING DE-BRANCHING OF THE INNOMINATE AND THE RIGHT COMMON CAROTID ARTERIES).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THIS WAS A COMPLEX THORACIC PROCEDURE REQUIRING DE-BRANCHING OF THE INNOMINATE AND THE RIGHT COMMON CAROTID ARTERIES. THE STENT GRAFTS WERE INSERTED AND IMPLANTED VIA A CONDUIT THAT WAS ANASTOMOSED TO THE ASCENDING THORACIC AORTA AFTER WHICH THE STENT GRAFTS WERE IMPLANTED IN THE DESCENDING AORTA STARTING DISTAL TO PROXIMAL. THE STENT GRAFTS WERE IMPLANTED IN THIS FASHION BECAUSE THE FEMORAL ARTERIES WERE TOO SMALL. THE PATIENT HAD A MAJOR STROKE POST IMPLANT AND AN EXTERNAL CEREBRAL FLOW MONITORING DEVICE WAS USED TO OBSERVE THE PATIENT. THE PATIENT EXPIRED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED (SEE MFR NUMBERS 2953200-2008-01102, 2953200-2008-01103 AND 2953200-2008-01104).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT XCELERANT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC VASCULAR NA V00164385

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death