BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1078735 · Received July 17, 2008

    Report

    Report Number
    2954310-2008-81659
    Event Type
    Injury
    Date Received
    July 17, 2008
    Date of Event
    January 1, 2001
    Report Date
    July 8, 2008
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF OUR INVESTIGATION, ATTEMPTS TO OBTAIN SPECIFIC DETAILS FROM THE AUTHOR REGARDING THE ANCURE DEVICES AND ANY ASSOCIATED COMPLICATIONS WERE UNSUCCESSFUL. WE ARE FILING AN MDR AT THIS TIME SINCE WE CANNOT DEFINITIVELY REFUTE THE POSSIBLE INVOLVEMENT OF THE ANCURE DEVICE NOR CONFIRM THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    THE FOLLOWING JOURNAL ARTICLE FROM 2006 WAS REVIEWED: ARTICLE CITATION: VAN DER LAN, M.J., BARTELS, L.W., VIERGEVER, M.A., AND BLANKENSTEIJN, J.D. (2006). COMPUTED TOMOGRAPHY VERSUS MAGNETIC RESONANCE IMAGING OF ENDOLEAKS AFTER EVAR. EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY. 32, 361-365. THE AIM OF THIS CASE STUDY WAS TO COMPARE THE SENSITIVITY OF CT AND MRI FOR THE DETECTION OF ENDOLEAK. THE PERIOD BETWEEN 2001 AND 2003, 28 PTS RANDOMLY SELECTED FROM AN EVAR FOLLOW-UP PROGRAM WERE INCLUDED IN THE STUDY (3 EXCLUDER PTS AND 25 ANCURE PTS). USING MFR TECHNOLOGY, 66% OF THE PTS REVIEWED EXHIBITED ENDOLEAKS WHILE ONLY 31% OF ENDOLEAKS WERE DETECTED USING CT TECHNOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCURE ENDOGRAFT GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention