BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1077967 · Received July 15, 2008

    Report

    Report Number
    2954310-2008-81654
    Event Type
    Injury
    Date Received
    July 15, 2008
    Date of Event
    February 1, 1993
    Report Date
    July 15, 2008
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT PERFORMANCE ISSUES REPORTED IN THE STUDY WERE: ONE PT EXHIBITED VASCULAR COMPLICATIONS DESCRIBED AS RUPTURE OF THE EXTERNAL ILIAC ARTERY. THIS WAS CAUSED DURING THE WITHDRAWAL OF THE INTRODUCER SHEATH AND RESOLVED WITH SUTURES. THREE PTS EXHIBITED REMOTE COMPLICATIONS DESCRIBED AS OBSTRUCTIVE RENAL IMPAIRMENT, CARDIAC ARRHYTHMIA AND STROKE AND/OR TRANSIENT ISCHEMIC ATTACK. FATIGUE FRACTURE HAD BEEN NOTED IN THE METALLIC ATTACHMENT SYSTEMS OF SOME EVT GRAFTS. ONLY ONE OCCURRED IN A HOOK ON THE INFERIOR ATTACHMENT SYSTEM. THERE WERE NO ADVERSE PT EFFECTS REPORTED WITH THIS FATIGUE FRACTURES. THE ARTICLE SPECIFICALLY STATED THAT THERE WERE NO ENDOLEAKS SEEN WITH EVT DEVICES. 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 1995 WAS REVIEWED: ARTICLE CITATION: MAY, J., WHITE, G.H., YU, W., WAUGH, R.C., STEPHEN, M. S., MCGAHAN, T.J., AND HARRIS, J. P., (1995) EARLY EXPERIENCE WITH SYDNEY AND EVT PROSTHESES FOR ENDOLUMINAL TREATMENT OF ABDOMINAL AORTIC ANEURYSM. JOURNAL OF ENDOVASCULAR SURGERY. 2, 240-247. THIS ARTICLE REVIEWED THE EARLY EXPERIENCES WITH THE SYDNEY AND EVT GRAFTS FOR TREATMENT OF AAA. THERE WERE 28 PTS ASSESSED IN THIS STUDY, 10 OF WHICH RECEIVED THE ANCURE GRAFT.

    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