BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 5094859 · Received September 22, 2015

    Report

    Report Number
    2954310-2015-81822
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: WALKER, J., TUCKER, L.Y., GOODNEY, P., CANDELL, L., HUA, HONG., OKUHN, S., HILL, B., AND CHANG, R.W. ADHERENCE TO ENDOVASCULAR AORTIC ANEURYSM REPAIR DEVICE INSTRUCTIONS FOR USE GUIDELINES HAS NO IMPACT ON OUTCOMES. JOURNAL OF VASCULAR SURGERY.2015; 60 (5); 1151-1159.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMERLY (B)(4)) RECEIVED INFORMATION FROM THIS JOURNAL ARTICLE OF A STUDY CONDUCTED TO ASSESS THE LONG-TERM ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR) OUTCOMES IN REGARDS TO ADHERENCE TO THE INSTRUCTIONS FOR USE (IFU) GUIDELINES. A TOTAL OF 489 PATIENTS WERE USED IN THE STUDY THAT SPANNED FROM 2000 TO 2010. IT WAS IDENTIFIED THAT DURING THE COURSE OF THE STUDY, THE OVERALL ALL-CAUSE MORTALITY AND ANEURYSM RELATED MORTALITY WERE UNAFFECTED BY IFU ADHERENCE. THE RATES OF ENDOLEAK AND RE-INTERVENTION AFTER INITIAL EVAR WERE SIMILAR; SUGGESTING THAT LACK OF IFU BASED ANATOMIC SUITABILITY WAS NOT A DRIVER OF PATIENT OUTCOMES. IN THIS STUDY, EVAR DEVICES FROM 6 DIFFERENT MANUFACTURERS WERE USED. THERE WAS ONLY ONE PATIENT THAT HAD A GUIDANT ANCURE GRAFT, AND THIS GRAFT WAS IMPLANTED IN A MANNER THAT DID NOT ADHERE TO THE IFU. NO SPECIFIC ADVERSE EFFECTS OR RE-INTERVENTIONS REPORTED WERE IDENTIFIED TO BE DIRECTLY RELATED TO THIS PARTICULAR GRAFT. THE SPECIFIC MODEL AND SERIAL NUMBER INFORMATION WAS NOT PROVIDED IN THE ARTICLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE NOT SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626664 ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT) GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1