BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2080595 · Received April 22, 2011

    Report

    Report Number
    2953200-2011-00867
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ENDOLEAK). RESULTS & CONCLUSION: (CARDIAC DETERIORATION), (STENT GRAFT WAS DEPLOYED OUTSIDE THE PT AND RELOADED INTO THE DELIVERY SYSTEM).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM THORACIC AORTIC ANEURYSM AT ZONE 4 APPROX ONE MONTH AGO. THE VESSELS WERE MODERATELY CALCIFIED AND MODERATELY TORTUOUS. THE PROXIMAL NECK DIAMETER IS 42 MM, THE DISTAL NECK DIAMETER IS 36MM. IT WAS NOTED THAT DURING PROCEDURE, THE PT'S BLOOD PRESSURE COULD NOT BE DECREASED AS THERE WAS DETERIORATION OF THE PT'S CARDIAC FUNCTION. IT WAS REPORTED THAT THE TW4036 WAS DEPLOYED OUTSIDE THE PT, AND RELOADED REVERSED INTO THE DELIVERY SYSTEM. THE STENT GRAFT WAS THEN IMPLANTED IN THE DISTAL PORTION OF THE ANEURYSM. THE SAME THING WAS DONE WITH A TAXF4040 AND IT WAS IMPLANTED DISTAL TO THE TW4036. AT THIS POSITION, THE DELIVERY SYSTEM WAS ALONG THE INNER CURVE OF AORTA. DURING THE EXPANSION OF TAXF4040, IT STARTED TO MISALIGN (REF MFR # 2953200-2011-00868). THEN A TAXF4040 WAS IMPLANTED TO THE TARGET THE AREA OF THE MISALIGNMENT. THERE WAS A TYPE III ENDOLEAK COMING FROM A GAP BETWEEN THE MISALIGNED STENT GRAFT AND THE TW4036. ANOTHER MFR'S STENT GRAFT WAS IMPLANTED AT THE PROXIMAL PORTION OF THE THORACIC AORTA. A TAXF4444 WAS IMPLANTED INTO THE PROXIMAL END OF THE OTHER MFR'S STENT GRAFT. A TAXF4242 WHICH WAS ALSO DEPLOYED OUTSIDE THE PT REVERSED AND RELOADED INTO THE DELIVERY SYSTEM WAS IMPLANTED TO COVER THE TYPE III ENDOLEAK AND FOR APPOSING THE MISALIGNED STENT GRAFT TO THE GRAFT WALL OF TW4036. THEN, TAXW4040 WAS IMPLANTED FOR COVERING THE JUNCTION OF THE OTHER MFR'S STENT GRAFT AND THE TW4036. THE TYPE III ENDOLEAK WAS CONFIRMED TO HAVE RESOLVED AND THE PROCEDURE WAS CONCLUDED. 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 THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00542666

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention