BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM (CT)

    MDR report key: 2050890 · Received April 1, 2011

    Report

    Report Number
    2953200-2011-00746
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: CVA/STROKE, PRE-OP DISSECTION, ANOTHER MANUFACTURER'S BALLOON, TREATMENT OF A PRE-OPERATIVE DISSECTION. CONCLUSION: PRE-OP DISSECTION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDO VASCULAR TREATMENT OF A SACCULAR DISTAL AORTIC ARCH ANEURYSM, AT ZONE 2, WITH A SEVERE TYPE B DISSECTION, 28 DAYS AGO. VESSEL MORPHOLOGY WAS REPORTED AS LITTLE CALCIFICATION; A PROXIMAL NECK DIAMETER OF 30-31MM; A DISTAL NECK DIAMETER OF 27MM; AND A 33MM ANEURYSM LENGTH. IT WAS REPORTED THAT ACCESS WAS NARROW AND A CONDUIT WAS CONSTRUCTED. THE TF3232 DEVICE WAS IMPLANTED INTO THE DISTAL END OF THE LESION AT THE LEFT COMMON CAROTID ARTERY, COVERING LEFT SUBCLAVIAN ARTERY (REF MFR #2953200-2011-00745). A TF3636 WAS IMPLANTED INTO THE PROXIMAL SIDE OF THE LESION. ANOTHER MANUFACTURER'S BALLOON WAS THEN USED. A TYPE IA ENDOLEAK WAS THEN NOTED. A TAX3636 WAS IMPLANTED SUCCESSFULLY TO TREAT THE ENDOLEAK (REF MFR # 2953200-2011-00747). AFTER TEVAR, WHEN THE PT AWAKED FROM ANESTHESIA, A CEREBRAL INFARCTION AND RIGHT HEMIPLEGIA WERE CONFIRMED. PT IS IN THE CCU AT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM (CT) NONE MIH MEDTRONIC IRELAND NA V00546241

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR