BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 1410676 · Received July 2, 2009

    Report

    Report Number
    2954310-2009-81723
    Event Type
    Injury
    Date Received
    July 2, 2009
    Date of Event
    January 1, 2000
    Report Date
    June 30, 2009
    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

    ATTEMPTS TO IDENTIFY PATIENT'S AND/OR MODEL-SERIAL NUMBERS WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    THIS EVENT WA CREATED FROM A JOURNAL ARTICLE IN THE EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY TITLED "DILATATION OF THE PROXIMAL NECK OF INFRARENAL AORTIC ANEURYSMS AFTER ENDOVASCULAR AAA REPAIR" EUR J VASC SURG 19, 297-201 (2000). ARTICLE CITATION: J. J. WEVER, A.J. DE NIE, J. D. BLANKENSTEIJN, I. A. M. J. BROEDERS, W. P. TH. M. MALI AND B. C. EIKELBOOM. THE ARTICLE REVIEWED ALL PATIENTS WHO UNDERWENT EVAR USING EVT ENDOGRAFTS. SOME OF THESE PATIENTS WERE FOLLOWED FOR LESS THAN 6 MONTHS, DUE TO OPERATIVE MORTALITY (1), NON-RELATED MORTALITY (1), AND CONVERSION (6). AS A RESULT, A TOTAL PATIENTS WERE INCLUDED IN THE STUDY. THERE WERE SOME FEMALES AND MALE PATIENTS WITH A MEDIAN AGE OF 69. THESE TOTAL PATIENTS EXPERIENCED 14 EARLY AND 8 LATE ENDOLEAKS. CLINICAL OBSERVATIONS: ENDOLEAKS, ANEURYSM GROWTH, UN-IDENTIFIED OPERATIVE MORTALITY, NON-RELATED MORTALITY AND CONVERSION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R