BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT CAPTIVIA THORACIC STENT GRAFT SYSTEM

    MDR report key: 1920717 · Received December 9, 2010

    Report

    Report Number
    2953200-2010-02502
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: BOVINE THORACIC ARCH AND ANGULATED AORTA. STENT GRAFT IMPLANTED IN PT WITH INADEQUATE ANATOMY. EVAL, CONCLUSION: BOVINE THORACIC ARCH AND ANGULATED AORTA. STENT GRAFT IMPLANTED IN PT WITH INADEQUATE ANATOMY.

    Description of Event or Problem · 1

    A TALENT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 7 CM LONG CHRONIC DISSECTING TAA. THE PT HAD A BOVINE ARCH THAT WAS EXTREMELY TORTUOUS, AND THERE WAS A 110 DEGREE ANGULATION IN THE TRANSVERSE AORTA BEFORE THE DESCENDING AORTA. ONE DEVICE WAS IMPLANTED IN THE ARCH AND LANDED AS PLANNED AT THE INNOMINATE ARTERY; HOWEVER, DUE TO THE SEVERE AORTIC ANGULATION, THERE WAS A KINK IN THE GRAFT BETWEEN THE FIRST AND SECOND COVERED STENTS ALONG THE LESSER CURVE OF THE AORTA. THE WIRE WAS ALSO HUGGING THE INNER AORTIC CURVE. DURING REMOVAL OF THE DELIVERY SYSTEM, THE PHYSICIAN TRIED TO ADVANCE THE SPINDLE BUT WAS UNABLE TO DUE TO THE INTERACTIONS BETWEEN THE DEVICE AND THE GRAFT AND THE SEVERE ANGLED ANATOMY. HOWEVER, BY PULLING THE TRIGGER AND MOVING THE GRAY HANDLE BACK AND FORTH, THE DELIVERY SYSTEM WAS ABLE TO BE WITHDRAWN WITHOUT ISSUES. THE KINKED GRAFT WAS LEFT UNCORRECTED. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE DELIVERY SYSTEM WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00558641

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR