BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2023188 · Received March 16, 2011

    Report

    Report Number
    2953200-2011-00651
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEATH), (ANTEGRADE INSERTION OF DEVICE). CONCLUSIONS: (ANTEGRADE INSERTION OF DEVICE).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM APPROX 18 MONTHS AGO. VESSEL MORPHOLOGY WAS REPORTED AS AN "ELEPHANT TRUNK" THORACIC AORTA, WHICH INVOLVED THE ANEURYSM. NO OTHER MORPHOLOGICAL INFO WAS AVAILABLE. IT WAS REPORTED THAT THE PT HAD A LARGE PROXIMAL TYPE I ENDOLEAK, WHICH EXTENDED ALONG THE PROXIMAL NECK, DUE TO DISEASE PROGRESSION. ONE MONTH AGO, THE DECISION WAS MADE TO IMPLANT A TALENT STENT GRAFT PROXIMALLY TO ADDRESS THE ENDOLEAK (SEE FILE #2953200-2011-00648). THE CHEST WAS OPENED AND THE DEVICES WERE DEPLOYED ANTEGRADE FROM THE ASCENDING THORACIC AORTA. THE STENT GRAFT WAS IMPLANTED PROXIMALLY AND THE ENDOLEAK WAS RESOLVED. AS THE PHYSICIAN WAS CLOSING THE PT, THERE APPEARED TO BE A TYPE III ENDOLEAK BETWEEN THE JUNCTION OF THE ORIGINAL PROXIMAL MAIN, THE NEWLY IMPLANTED STENT GRAFT (SEE FILE #2953200-2011-00649). THE PHYSICIAN REOPENED THE PT AND PUT ANOTHER STENT GRAFT IN AND STATED THAT THE STENT GRAFT LOOKED COMPRESSED. THE DECISION WAS MADE TO CONVERT THE PT TO OPEN REPAIR (SEE FILE #2953200-2011-00650); HOWEVER, THE PT DIED DURING THE PROCEDURE (SEE FILE 2953200-2011-00652).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00219913

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death