BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA STENT GRAFT SYSTEM

    MDR report key: 1833626 · Received September 8, 2010

    Report

    Report Number
    2953200-2010-01714
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: PARALYSIS.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF THREE THORACIC AORTIC ANEURYSMS. THE PATIENT HAD A BOVINE AORTIC ARCH AND A PREVIOUSLY-PLACED INFRARENAL ABDOMINAL AORTIC ANEURYSM STENT GRAFT FROM ANOTHER MANUFACTURER. THE NATIVE THORACIC AORTA IS ABOUT 36 MM IN DIAMETER. ACCESS VESSELS HAD MILD CALCIFICATION. IT WAS REPORTED THAT A TALENT CAPTIVIA STENT GRAFT WAS DELIVERED EASILY TO THE TARGET ZONE AND IMPLANTED PROXIMALLY. THEN, TWO TALENT THORACIC DISTAL MAIN STENT GRAFTS (MFR REPORT # 2953200-2010-01715 AND 01716) WERE DEPLOYED, ALTHOUGH THERE WAS SOME DIFFICULTY REACHING THE ANEURYSMS. THE CASE WENT VERY WELL WITH GOOD PLACEMENT OF THE STENT GRAFTS. APPROXIMATELY 30 MINUTES POST-IMPLANTATION, WHEN THE PHYSICIAN WAS CLOSING THE GROIN, A CHECK ON THE PATIENT STATUS REVEALED THAT THERE WAS PARAPLEGIA IN THE RIGHT LEG, ALTHOUGH THE LEFT LEG WAS FINE. A SPINAL DRAIN WAS THEN PLACED TO INTERVENE, AND THE PARALYSIS WAS RESOLVED; THE PATIENT HAS REGAINED RIGHT LEG MOBILITY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE. PLEASE NOTE THAT THIS DEVICE THE TALENT CAPTIVIA STENT GRAFT SYSTEM IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT TALENT THORACIC STENT GRAFT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00422812

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention