BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM (CT)

    MDR report key: 1881437 · Received October 7, 2010

    Report

    Report Number
    2953200-2010-01905
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), EVAL RESULTS/CONCLUSIONS: PLACEMENT OF A DEVICE WITH A HOME MADE DEVICE; LOSING GUIDEWIRE POSITIONING.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A TYPE A AND B DISSECTION AT ZONE 4 AND AN ANEURYSM IS 193 MM IN LENGTH AND 82 MM IN DIAMETER. THE PROXIMAL DIAMETER OF THE THORACIC AORTA WAS 28.4 MM AND DISTAL DIAMETER OF THE THORACIC AORTA WAS 40.9 MM. THE PT'S ENTIRE THORACIC ARCH AND DESCENDING AORTA WAS TREATED WITH A HOME MADE DEVICE, A TALENT 4642 (UPSIDE-DOWN) STENT GRAFT AND TWO DISTAL EXTENSIONS. IT WAS REPORTED DURING INITIAL IMPLANTATION, THERE WAS A DISTAL TYPE I ENDOLEAK THAT WAS TREATED WITH 2 EXTENSIONS (MFR: 2953200-2010-001904) AND THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. IT WAS REPORTED THAT ONE WEEK LATER THE PT HAD A FOLLOW-UP, AND THERE WAS A TYPE III ENDOLEAK BETWEEN THE HOMEMADE STENT GRAFT AND THE TALENT STENT GRAFT. THE PHYSICIAN IMPLANTED A TALENT THORACIC 4444 TO TREAT THE TYPE III ENDOLEAK. THE PHYSICIAN THEN ELECTED TO PLACE A SECOND TAXFF4444, BUT LOST GUIDE WIRE POSITIONING. THE PHYSICIAN ATTEMPTED, BUT WAS UNABLE TO PUT THE GUIDE WIRE BACK TO THE ORIGINAL POSITION. THE PHYSICIAN WAS UNABLE TO ADVANCE THE WIRE PAST THE CONE. THEREFORE THE PHYSICIAN EXCHANGED THE WIRE FOR A LUNDERQUIST, BUT IT WAS ALSO STUCK. AT LAST, THE PHYSICIAN USED A KTI22FR SHEATH TO ADVANCE THE TAXF4444 TO THE INTENDED LANDING ZONE AND WAS ABLE TO IMPLANT THE STENT GRAFT. NO ADDITIONAL 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 (CT) MIH MEDTRONIC CARDIOVASCULAR NA V00328421

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR