BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 2852969 · Received November 30, 2012

    Report

    Report Number
    2953200-2012-02294
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    March 8, 2011
    Report Date
    November 2, 2012
    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: DISSECTION. TREATMENT OF A PRE-OPERATIVE DISSECTION. CONCLUSIONS: TREATMENT OF A PRE-OPERATIVE DISSECTION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM 6 CM IN DIAMETER AND 12 CM IN LENGTH CHRONIC B TYPE DISSECTION AND ANEURYSM IN ZONE 4. THE PROXIMAL NECK WAS 28 MM IN DIAMETER AND THE DISTAL AORTIC NECK WAS 25 MM IN DIAMETER. THERE WAS MODERATE CALCIFICATION IN THE ILIAC ARTERIES, PROXIMAL AORTIC NECK AND THE DISTAL AORTIC NECK. THERE WAS SEVERE THROMBOSIS AT THE PROXIMAL AND DISTAL AORTA. IT WAS REPORTED AT THE 30 DAY FOLLOW UP THE ANEURYSM MEASURED 57 MM IN DIAMETER AND THERE WAS A LOCALIZED DISSECTION NOTED AT THE LOCATION OF THE TAXF3434W48XJ. THE PHYSICIAN BELIEVES THE DISSECTION OCCURRED AFTER TEVAR AND WILL MONITOR THE PATIENT. ONE YEAR POST INDEX PROCEDURE THE PHYSICIAN STATED THAT THE DISSECTION AREA WAS HARD TO LOCATE AND BELIEVES THE PATIENT RECOVERED. THE PHYSICIAN STATED THAT THIS CASE OCCURRED DUE TO THE PATIENT'S BLOOD VESSEL CONDITION AND WAS NO RELATION TO THE TALENT OR THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00540702

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR