BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 5667374 · Received May 19, 2016

    Report

    Report Number
    2954310-2016-81825
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    December 1, 2015
    Report Date
    April 26, 2016
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ANCURE PRODUCTS FROM THE ARTICLE AUTHOR WERE UNSUCCESSFUL. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. REFERENCE: LAL, B.K., ZHOU, W., LI, ZIYI, KYRIAKIDES, T., MATSUMURA, J., LEDERLE, F.A., AND FREISCHLAG, J. PREDICTORS AND OUTCOMES OF ENDOLEAKS IN THE VETERANS AFFAIRS OPEN VERSUS ENDOVASCULAR REPAIR (OVER) TRIAL OF ABDOMINAL AORTIC ANEURYSMS. JOURNAL OF VASCULAR SURGERY. 2015; 62 (6): 1394-1404.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMERLY GUIDANT) RECEIVED INFORMATION FROM THIS JOURNAL ARTICLE OF A STUDY CONDUCTED TO COMPARE OPEN VS ENDOVASCULAR REPAIR (EVAR) IN STANDARD-RISK PATIENTS WITH INFRA-RENAL AORTIC ANEURYSMS. THE ARTICLE REPORTED THAT ENDOGRAFTS WERE USED FROM SEVERAL DIFFERENT MANUFACTURERS, INCLUDING BOSTON SCIENTIFIC. THE ARTICLE REPORTED THAT ONE ANCURE ENDOGRAFT RESULTED IN A TYPE I ENDOLEAK. NO SPECIFIC MODEL AND SERIAL INFORMATION WAS LISTED IN THE ARTICLE. THE ONLY PATIENT INFORMATION PROVIDED WAS THAT ALL PATIENTS WHO EXPERIENCED ENDOLEAKS WERE MALE. IT IS UNKNOWN IF ANY INTERVENTIONS WERE PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321965 ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT) GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R