BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1393375 · Received May 22, 2009

    Report

    Report Number
    2953200-2009-00649
    Event Type
    Death
    Date Received
    May 22, 2009
    Date of Event
    April 28, 2009
    Report Date
    April 28, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: EVALUATION OF THE EXPLANTED STENT GRAFT IS PENDING, FILM REVIEW IS PENDING, UNKNOWN CAUSE OF THEY 3 ENDOLEAK. ENDOLEAK, DEATH. TYPE 2 ENDOLEAK. CONCLUSION: EVALUATION OF THE EXPLANTED STENT GRAFT IS PENDING, FILM REVIEW IS PENDING, UNKNOWN CAUSE OF TYPE 3 ENDOLEAK. TYPE 2 ENDOLEAK.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT AN ILIAC EXTENSION STENT GRAFT WAS EXPLANTED DUE OT AN EXPANDING AORTIC ANEURYSM FOLLOWED BY A FEM-FEM BYPASS. THE ANEURYSM EXPANSION WAS LIKELY DUE TO A TYPE 3 ENDOLEAK IN THE ILIAC EXTENSION WHICH WAS NOT VISIBLE ON CT BUT VISIBLE DURING SURGERY. THE REMAINING MODULES OF THE ENDOGRAFT WERE LEFT IN SITU. THE ILIAC EXTENSION STENT GRAFT WAS THE ONLY COMPONENT THAT WAS COMPROMISED AND IT WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE PATIENT WAS FINE AFTER THE EXPLANT PROCEDURE, BUT EXPIRED A FEW DAYS LATER. THE PATIENT'S DEATH WAS DUE TO CO-MORBIDITIES AND THE DEVICE WAS NOT A CONTRIBUTING FACTOR. IT WAS ALSO DOCUMENTED IN A CT ANGIOGRAM APPROXIMATELY 2 MONTHS PRIOR TO THE PATIENT'S DEATH THERE WAS A PROMINENT TYPE 2 ENDOLEAK. THE CONFIGURATION OF THE GRAFT IS NOT CHANGED IN INTERVAL SINCE THE PATIENT'S LAST CT FROM 2 YEARS AGO. THERE WAS CONSIDERABLE REMODELLING OF THE ANEURYSM SAC WHEN COMPARED WITH THE PREVIOUS STUDY. EVALUATION OF THE EXPLANTED STENT GRAFT IS PENDING. PLEASE NOTE THAT THIS MODEL NUMBER IXW1816C14AX IS NOT APPROVED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE IXW1816C14CT WHICH IS APPROVED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 528599

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death