BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT TAA

    MDR report key: 4305401 · Received December 8, 2014

    Report

    Report Number
    2953200-2014-02577
    Event Type
    Injury
    Date Received
    December 8, 2014
    Date of Event
    November 10, 2014
    Report Date
    November 11, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT TAA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ULCER. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. IT WAS REPORTED THAT PATIENT PRESENTED WITH PAIN. THE CT REVEALED THAT THERE WAS PENETRATING ULCERS PROXIMAL AND DISTAL TO THE TALENT STENT GRAFT. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THE ULCERS. THE PHYSICIAN ELECTED TO IMPLANT A VALIANT PROXIMAL MAIN DEVICE AND THE ULCERS PROXIMAL AND DISTAL WERE COVERED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. REVIEW OF RETURNED CTA¿S FROM 4 YEARS POST-IMPLANT REVEALED THAT A SINGLE TALENT STENT GRAFT WAS IMPLANTED INTO THE DESCENDING THORACIC AORTA. THERE IS LITTLE OR NO PROXIMAL OR DISTAL SEALING ACROSS THE ANEURYSM/PU; HOWEVER, NO CONTRAST COULD BE SEEN IN THE THORACIC ANEURYSM WHICH MEASURED APPROXIMATELY 6.3CM MAXIMUM DIAMETER. IT IS UNKNOWN IF THE TAA SAC MAY BE PRESSURIZED. THE PROXIMAL STENT GRAFT OD IS 35 X 37MM AND THE NECK DIAMETER ABOVE THE STENT GRAFT IS 36MM. THE DISTAL STENT GRAFT OD IS 37 X 40MM AND THE NECK DIAMETER BELOW THE STENT GRAFT IS 35X37MM. THE STENT GRAFT IS PATENT. NO OTHER STENT GRAFT ISSUES ARE SEEN. THE CAUSE OF THE REPORTED PENETRATING ULCERS/ TAA SEEN ALONG THE LENGTH OF THE STENT GRAFT IS UNKNOWN. EARLIER FOLLOW-UP IMAGES WERE NOT RETURNED, AND IMAGES POST INTERVENTIONS WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790795 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00384219

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention