BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1410679 · Received July 2, 2009

    Report

    Report Number
    2954310-2009-81721
    Event Type
    Injury
    Date Received
    July 2, 2009
    Report Date
    June 25, 2009
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 WAS CREATED FROM A JOURNAL ARTICLE IN THE ANNALS OF VASCULAR SURGERY, TITLED "PROXIMAL TYPE I ENDOLEAK AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR: PREDICTIVE FACTORS" ANN VASC SURG 2004; 18: 621-628. ARTICLE CITATION: SERGIO M. SAMPAIO, MD, JEAN M. PANNETON, MD, GEZA I. MOZES, MD, JAMES C. ANDREWS, MD,4 THOMAS C. BOWER, MD, MANJU KARLA, MB, BS, AUDRA A. NOEL, MD, KENNETH J. CHERRY, MD, TIMOTHY SULLIVAN, MD, AND PETER GLOVICZKI, MD, ROCHESTER, MINNESOTA AND NORFOLK, VIRGINIA. THE ARTICLE REVIEWED 202 PATIENTS WHOSE RECORDS INCLUDED THE PREOPERATIVE AND AT LEAST ONE POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN. OF WHICH 38 OF 202 WERE IMPLANTED WITH AN ANCURE ENDOGRAFT. ONE PATIENT SURVIVED AN EMERGENCY OPEN REPAIR OF A RUPTURED ANEURYSM AFTER SIGNIFICANT EXPANSION. CLINICAL OBSERVATIONS: TYPE ONE ENDOLEAKS, GRAFT MIGRATION, ANEURYSM GROWTH, AND ANEURYSM RUPTURE, REQUIRING SURGICAL INTERVENTION.

    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 Hospitalization| L| R