BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA STENT GRAFT SYSTEM

    MDR report key: 1993731 · Received February 11, 2011

    Report

    Report Number
    2953200-2011-00384
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 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
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (INACCURATE PLACEMENT, ENDOLEAK), (CHALLENGING ANATOMY WHICH WAS DIFFICULT TO VISUALIZE AND DISEASE PROGRESSION). EVAL, CONCLUSION: (CHALLENGING ANATOMY WHICH WAS DIFFICULT TO VISUALIZE AND DISEASE PROGRESSION).

    Description of Event or Problem · 1

    A TALENT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION THAT TURNED INTO THORACIC AORTIC ANEURYSM APPROX 3 MONTHS AGO. AT THE TIME OF THE INITIAL IMPLANTATION THE VESSEL MORPHOLOGY WAS REPORTED AS CHALLENGING ANATOMY WHICH WAS DIFFICULT TO VISUALIZE. THE CONNECTING BAR WAS ON THE INFERIOR CURVE OF THE AORTIC ARCH. IT WAS REPORTED THAT THE PT CONTINUED TO HAVE DEGENERATION OF THE AORTA, PROXIMAL AND DISTAL TO THE STENT GRAFT AND THERE WAS A PROXIMAL TYPE I ENDOLEAK (REF MFR 2953200-2011-00385). CURRENTLY THERE IS DISEASE PROGRESSION PROXIMAL AND DISTAL TO THE STENT GRAFT. THE DAY PRIOR TO RE-INTERVENTION ONE MONTH AGO THE PHYSICIAN PERFORMED AN LSA TO THE LCA BYPASSED. THE PHYSICIAN ELECTED TO EXTEND THE EXISTING STENT GRAFT PROXIMALLY TO TREAT THE PROXIMAL TYPE I ENDOLEAK WITH ANOTHER TALENT CAPTIVIA. THREE VESSELS APPEARED TO BE COMING OFF THE THORACIC AORTA. DURING THE IMPLANTATION OF THE SECOND DEVICE THE LSA WAS MISTAKEN FOR THE LCA RESULTING IN INACCURATE PLACEMENT OF THE STENT GRAFT WITH A TYPE I ENDOLEAK. AFTER THAT THEY REALIZED THAT THE STENT GRAFT WAS INACCURATELY DEPLOYED AT THE LSA. ANOTHER STENT GRAFT WAS DEPLOYED AT THE LCA AND THE TYPE I ENDOLEAK WAS RESOLVED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CAPTIVIA STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00557133

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention