BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 5666927 · Received May 19, 2016

    Report

    Report Number
    2954310-2016-81831
    Event Type
    Injury
    Date Received
    May 19, 2016
    Date of Event
    May 30, 2014
    Report Date
    April 26, 2016
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: WU, Z., XU, L., QU, L., AND RAITHEL, D. SEVENTEEN YEARS' EXPERIENCE OF LATE OPEN SURGICAL CONVERSION AFTER FAILED ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR WITH 13 VARIANT DEVICES. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. 2015; 38; 53-59.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMERLY GUIDANT) RECEIVED INFORMATION FROM THIS JOURNAL ARTICLE OF A STUDY CONDUCTED TO INVESTIGATE THE CAUSES AND RESULTS OF LATE OPEN SURGICAL CONVERSION (LOSC) AFTER FAILED ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) AND TO SUMMARIZE OUR 17 YEARS' EXPERIENCE WITH 13 VARIOUS ENDOGRAFTS FROM DIFFERENT MANUFACTURERS. A TOTAL OF 1729 ENDOVASCULAR ANEURYSM REPAIRS WERE PERFORMED IN OUR SINGLE CENTER ((B)(6)) WITH 13 VARIOUS DEVICES WITHIN 17 YEARS. THERE WERE FOUR PATIENTS WITH ANCURE ENDOGRAFTS THAT UNDERWENT A LATE OPEN SURGICAL CONVERSION. TWO PATIENTS, WITH ANCURE TUBE ENDOGRAFTS, EXPERIENCED TYPE IB ENDOLEAKS. A THIRD PATIENT, WITH AN ANCURE BIFURCATED ENDOGRAFT, EXPERIENCED A TYPE IA ENDOLEAK. THE FOURTH PATIENT, WITH AN ANCURE BIFURCATED ENDOGRAFT, EXPERIENCED AN ENDOGRAFT THROMBOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE MODEL AND SERIAL INFORMATION AND THE PATIENT INFORMATION WERE NOT PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321137 ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT) GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R