BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 2097874 · Received May 4, 2011

    Report

    Report Number
    2954310-2011-81794
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    June 1, 2010
    Report Date
    April 11, 2011
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADD'L INFO FROM THE ARTICLE AUTHOR(S) WERE UNSUCCESSFUL. THE FINDINGS OF THE STUDY WERE SUMMARIZED IN THE ARTICLE: THOMAS BG, SANCHEZ LA, GERAGHTY PJ, RUBIN BG, MONEY SR, SICARD GA. A COMPARATIVE ANALYSIS OF THE OUTCOMES OF AORTIC CUFFS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMERLY GUIDANT) REC'D INFO FROM A STUDY DESIGNED TO COMPARE ANALYSIS OF THE OUTCOMES OF AORTIC CUFFS AND CONVERTERS FROM ENDOVASCULAR GRAFT MIGRATION. THE STUDY INVOLVED A TOTAL OF 151 PTS. GUIDANT ANCURE ENDOGRAFT'S WERE IMPLANTED IN NINE PTS IN THE STUDY. DURING THE 32 MONTHS F/U, REPORTED ADVERSE PT EFFECTS INCLUDING: MIGRATION, CONVERSION PROCEDURE TO OPEN REPAIR, ADD'L PROCEDURE FOR PLACEMENT OF ANOTHER MFRS STENT, TYPE I, II, AND III ENDOLEAKS, GROWTH OF ANEURYSM, AND ANEURYSM RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT) GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R