BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1924212 · Received December 7, 2010

    Report

    Report Number
    2953200-2010-02433
    Event Type
    Death
    Date Received
    December 7, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (DEATH, ENDOLEAK), (SPECIFIC INFORMATION RELATED TO EACH PATIENT WAS NOT PROVIDED). CONCLUSION: (DEATH, ENDOLEAK), (SPECIFIC INFORMATION RELATED TO EACH PATIENT WAS NOT PROVIDED).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING JOURNAL ARTICLE WHICH IS SUMMARIZED AS FOLLOWS: LONG-TERM RESULTS OF TALENT ENDOGRAFTS FOR ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. MANUSCRIPT NUMBER (B)(4). ARTICLE TYPE: CLINICAL PAPER. BACKGROUND: SINCE THE INTRODUCTION OF ENDOVASCULAR ANEURYSM REPAIR (EVAR), LONG-TERM FOLLOW-UP STUDIES REPORTING SINGLE-DEVICE RESULTS ARE SCARCE. IN THIS STUDY, WE FOCUS ON EVAR REPAIR WITH THE TALENT ENDOGRAFT. BETWEEN (B)(6) 2000 AND (B)(6) 2007, 365 PATIENTS UNDERWENT ELECTIVE EVAR WITH A TALENT DEVICE. THE MEAN PROXIMAL AORTIC NECK DIAMETER WAS 27 MM (RANGE, 16-36 MM), WITH A NECK LENGTH OF 15 MM. DEPLOYMENT OF ENDOGRAFTS WAS SUCCESSFUL IN 361 OF 365 PATIENTS (99%). INITIALLY, CONVERSION TO LAPAROTOMY WAS NECESSARY IN FOUR PATIENTS. PRIMARY TECHNICAL SUCCESS DETERMINED BY RESULTS FROM CT SCANS BEFORE DISCHARGE WAS ACHIEVED IN 333 PATIENTS. PROXIMAL TYPE 1 ENDOLEAKS WERE PRESENT IN 28 PATIENTS (8%) DURING FOLLOW-UP, AND 14 OF THESE PATIENTS NEEDED ADDITIONAL TREATMENT FOR TYPE 1 ENDOLEAK. THE 30-DAY MORTALITY FOR THE WHOLE TALENT GROUP WAS 1.1% (4 OF 365). FOLLOW-UP TO 84 MONTHS IS REPORTED FOR 24 PATIENTS. DURING FOLLOW-UP, 122 (33%) PATIENTS DIED; IN 9, DEATH WAS AAA-RELATED (INCLUDING 30-DAY MORTALITY). KAPLAN-MEIER ESTIMATES REVEALED PRIMARY CLINICAL SUCCESS RATES OF 98% AT 1 YEAR, 93% AT 2 YEARS, 88% AT 3 YEARS, 79% AT 4 YEARS, 64% AT 5 YEARS, 51% AT 6 YEARS, AND 48% AT 7 YEARS. SECONDARY INTERVENTIONS WERE PERFORMED IN 66 OF 365 PATIENTS (18%). TEN CONVERSIONS FOR FAILED ENDOGRAFTS WERE PERFORMED. LIFE-TABLE YEARLY RISK FOR AAA-RELATED REINTERVENTION WAS 6%, YEARLY RISK FOR CONVERSION TO OPEN REPAIR WAS 1.1%, AND YEARLY RISK FOR AAA-RELATED MORTALITY WAS 0.8%. INITIALLY TECHNICAL SUCCESS OF EVAR USING THE TALENT ENDOGRAFT IS HIGH, WITH ACCEPTABLE YEARLY RISK FOR AAA-RELATED MORTALITY AND CONVERSION. HOWEVER, A SUBSTANTIAL AMOUNT OF MAINLY ENDOVASCULAR RE-INTERVENTION IS NECESSARY DURING LONG-TERM FOLLOW-UP TO ACHIEVE THESE RESULTS. ADDITIONAL INFORMATION WAS REQUESTED IN ORDER TO FIND OUT SPECIFIC INFORMATION RELATED TO EACH EVENT, SUCH AS THE LOT NUMBER, IMPLANT DATE, INTERVENTION, AND PATIENT OUTCOME. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| R