BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 5667371 · Received May 19, 2016

    Report

    Report Number
    2954310-2016-81824
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    October 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. REFERENCE: DAVILA, V.J., STONE, W., DUNCAN, A.A., WOOD, E., JORDAN, W.D., ZEA, N., STERNBERGH, C.W., AND MONEY, S.R. A MULTICENTER EXPERIENCE WITH THE SURGICAL TREATMENT OF INFECTED ABDOMINAL AORTIC ENDOGRAFTS. JOURNAL OF VASCULAR SURGERY. 2015; 62 (4); 877-883.

    Description of Event or Problem · 1

    THE PURPOSE OF THIS STUDY WAS TO PERFORM A MULTICENTER REVIEW OF THE SURGICAL CARE OF PATIENTS BEING TREATED FOR INFECTED ENDOGRAFTS AFTER ENDOVASCULAR AORTIC REPAIR (I-EVAR) TO ELUCIDATE SHORT-TERM AND LONG-TERM OUTCOMES. THE ARTICLE REPORTED THAT ONE ANCURE ENDOGRAFT WAS EXPLANTED FROM A PATIENT BEING FOLLOWED IN THE STUDY. THE REASON FOR THE EXPLANT WAS NOT PROVIDED IN THE TABLE OR WITHIN THE BODY OF THE ARTICLE. THE SPECIFIC MODEL AND SERIAL NUMBER INFORMATION WAS NOT PROVIDED IN THE ARTICLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AN ATTEMPT WAS MADE TO OBTAIN THE MODEL AND SERIAL INFORMATION ON THIS ENDOGRAFT; HOWEVER, THE AUTHOR INFORMED BOSTON SCIENTIFIC THAT THIS WAS A BLINDED STUDY SO THAT INFORMATION WAS NEVER MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320816 ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT) GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R