BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA

    MDR report key: 2884075 · Received December 21, 2012

    Report

    Report Number
    2953200-2012-02477
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (CVA/STROKE, PARALYSIS); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (HISTORY OF CVA/STROKE). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (HISTORY OF CVA/STROKE).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 3.4 CM IN LENGTH THORACIC PENETRATING ATH EROSCLEROTIC ULCER. THE PROXIMAL AORTA WAS 32-31 MM IN DIAMETER AND 20MM IN LENGTH AT TOP OF ARCH AND 2MM IN LENGTH AT THE BOTTOM OF ARCH. DISTAL AORTA WAS 24-26 MM IN DIAMETER WITH LENGTH OF 80MM. RIGHT AND LEFT ILIAC ARTERIES WERE 7 AND 5MM IN DIAMETER CONSECUTIVELY. THE RIGHT AND LEFT COMMON ILIACS WERE 10MM IN DIAMETER. THE ACCESS VESSELS HAD MODERATE CALCIFICATION AND THE AORTIC NECK HAD MURAL THROMBUS. THE AORTA HAS MILD TORTUOSITY. THE STENT GRAFTS WERE IMPLANTED THROUGH THE RIGHT FEMORAL ARTERY IN ZONE 2 OR 3 WITH AN APPROXIMATE ANGULATION OF 68 DEGREE. PRIOR TO STENT GRAFT IMPLANT THE PHYSICIAN PERFORMED A CAROTID ARTERY TO SUBCLAVIAN ARTERY BYPASS. THE LSA WAS INTENTIONALLY COVERED COMPLETELY. IT WAS REPORTED APPROXIMATELY ONE WEEK POST INDEX PROCEDURE THE PATIENT HAD A NEUROLOGIC COMPLICATION (PARAPARESIS) AND SPECIFIED AS "EMBOLIC ISCHEMIC STROKE," WHICH REQUIRED HOSPITALIZATION AND TREATED WITH MEDICATION, USE OF DIAGNOSTIC ANGIOGRAPHY, AND PHYSICAL THERAPY. THIS EVENT IS STILL CONTINUING AND BEING TREATED. THE INVESTIGATOR ASSESSED THIS EVENT TO BE RELATED TO THE STUDY PROCEDURE BUT NOT RELATED TO THE STUDY DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01042122

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR