BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT CAPTIVIA

    MDR report key: 3951320 · Received July 22, 2014

    Report

    Report Number
    2953200-2014-01440
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 30, 2014
    Report Date
    August 6, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH THROMBOSIS AND ARM SWELLING RELATED TO THE SECONDARY PROCEDURE. THE PATIENT WAS ANTICOAGULATED AND DISCHARGED A FEW DAYS LATER. INVESTIGATOR ASSESSED THIS EVENT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60.9MM THORACIC AORTIC ANEURYSM. CURRENT VESSEL MORPHOLOGY WAS REPORTED AS THE DIAMETER CAUDAL TO THE LEFT CAROTID ARTERY WAS 30.6MM AND THE DIAMETER CAUDAL TO THE LEFT SUBCLAVIAN ARTERY WAS 36MM. THE DISTAL DIAMETER OF THE PROXIMAL AORTIC NECK WAS 40.3MM AND 7MM IN LENGTH. THE CURRENT ANEURYSM SIZE IS 68MM. DURING A FOLLOW UP VISIT, THE PHYSICIAN IDENTIFIED A TYPE IA ENDOLEAK AND A TYPE IB. THE PHYSICIAN ATTRIBUTED THE EVENTS DUE TO THE CONICAL NECK AND DISEASE PROGRESSION. A SECONDARY PROCEDURE WAS PERFORMED TO RESOLVE THE TYPE IA AND TYPE IB ENDOLEAK. A 46 X 46 X 150 MM VALIANT STENT GRAFT WAS ADVANCED. IT WAS PLACED AT THE LEVEL OF THE LEFT COMMON CAROTID ARTERY WHILE COVERING THE LEFT SUBCLAVIAN ARTERY. THE LSA WAS SNORKELED. THE 46 X 42 X 150 MM VALIANT STENT GRAFT WAS ADVANCED AND WAS OVERLAPPED WITH THE FIRST STENT GRAFT. USING A 44 X 44 X 100 MM DISTAL BARE SPRING STENT GRAFT WAS ADVANCED OVERLAPPING WITH THE PRIOR STENTS AND DEPLOYED UP TO THE CELIAC ARTERY. THE INTERVENTION WAS COMPLETED SUCCESSFULLY AND BOTH ENDOLEAKS WERE RESOLVED. NO ADDITIONAL CLINICAL S EQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. THE REVIEW OF RETURNED FILMS 3 YEARS POST-IMPLANT REVEALED THAT THE STENT GRAFTS WERE IMPLANTED FROM JUST DISTAL TO THE LSA, EXTENDING DISTALLY INTO THE DESCENDING THORACIC AORTA APPROX 2CM SHORT OF THE CELIAC. THERE IS A PROXIMAL TYPE I ENDOLEAK AND A DISTAL TYPE I ENDOLEAK. THE MAXIMUM SIZE TAA IS 6CM. THE STENT GRAFT PROXIMAL OD IS APPROXIMATELY 35MM AT THE LEVEL OF THE LSA, AND JUST PROXIMAL TO THIS LOCATION THE AORTIC MEASURES 30MM. THE MOST DISTAL STENT GRAFT DISTAL OD IS 45MM, AND JUST DISTAL TO THE AORTIC DIAMETER IS 36MM. EARLIER POST-IMPLANT FILMS, AND FILMS DURING THE INTERVENTION TO RESOLVE THE ENDOLEAKS, WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428404 TALENT CAPTIVIA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00848372

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention