BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TALENT TAA

    MDR report key: 4182468 · Received October 17, 2014

    Report

    Report Number
    2953200-2014-02116
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    December 9, 2013
    Report Date
    September 24, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM THORACIC AORTIC ANEURYSM IN ZONE 1. THIS REQUIRED THE COMMON CAROTID ARTERIES TO BE DE-BRANCHED PRIOR TO THE PROCEDURE. IT WAS REPORTED THAT THE FEMORAL ILIAC ARTERIES WERE TOO THIN TO USE AS ACCESS; THEREFORE, THE PHYSICIAN USED THE ASCENDING AORTA APPROACH. ANOTHER MANUFACTURER'S STENT GRAFT WAS IMPLANTED AT THE DISTAL END OF THE ANEURYSM, FOLLOWED BY THE TALENT STENT GRAFT WHICH WAS IMPLANTED PROXIMALLY. A TYPE 1 ENDOLEAK WAS DETECTED. THE DECISION WAS MADE TO IMPLANT TALENT THORACIC CUFF WAS IMPLANTED, THE ENDOLEAK RESOLVED. THE PHYSICIAN'S COMMENT WAS THAT THERE WAS NO OTHER WAY TO ACCESS ANEURYSM AND THIS PATIENT HAS KIDNEY INSUFFICIENCY, SO IT WAS NOT POSSIBLE TO CONFIRM THE STATUS OF THE ENDOLEAK VIA CONTRAST RADIOGRAPHY. IT WAS REPORTED THAT AT THE 3 YEAR FOLLOW UP THE ANEURYSM WAS 62 MM IN DIAMETER AND THERE WAS A TYPE I ENDOLEAK. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENT IS NOT RELATED TO THE PRODUCT OR THE PROCEDURE. THE PHYSICIAN IS MONITORING THE PATIENT. THE PHYSICIAN COMMENTED THAT THE CT SHOWED THE TYPE IA ENDOLEAK. THE PATIENT HAS BEEN MONITORED DUE TO AGE. THE CAUSE OF THIS EVENT CAN BE ENLARGEMENT OF THE NORMAL BLOOD VESSEL FROM 40MM TO 59MM, WHICH IS AT THE ASCENDING PART OF THE STENT PLACEMENT SITE. THEREFORE, THIS EVENT COULD BE ATTRIBUTED TO THE NATURE OF THE BLOOD VESSEL IN QUESTION AND THUS CONSIDERED THAT NEITHER THE PRODUCT NOR THE PROCEDURE IS RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660399 TALENT TAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00540758

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR