BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 4531624 · Received February 17, 2015

    Report

    Report Number
    2954310-2015-81821
    Event Type
    Injury
    Date Received
    February 17, 2015
    Date of Event
    January 15, 2014
    Report Date
    January 22, 2015
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: SCALI, S.T., MCNALLY, M.M., FEEZOR, R.J., CHANG, C.K, WATERMAN, A.L., BERCELI, S.A, HUBER, T.S., AND BECK, A.W. ELECTIVE ENDOVASCULAR AORTIC REPAIR CONVERSION FOR TYPE IA ENDOLEAK IS NOT ASSOCIATED WITH INCREASED MORBIDITY OR MORTALITY COMPARED WITH PRIMARY JUXTARENAL ANEURYSM REPAIR. JOURNAL OF VASCULAR SURGERY. 2014; 60 (2) : 286-294.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMERLY GUIDANT) RECEIVED INFORMATION FROM THIS JOURNAL ARTICLE OF A STUDY CONDUCTED TO ANALYZE OUTCOMES OF ELECTIVE OPEN SURGICAL CONVERSION (OSC) FOR TYPE IA ENDOLEAK AND COMPARE THEM WITH ELECTIVE PRIMARY OPEN JUXTARENAL ANEURYSM REPAIR (OJAR) TO DETERMINE IF THERE ARE LESS ISSUES WITH PATIENT MORBIDITY AND MORTALITY. THE PATIENTS THAT WERE A PART OF THIS STUDY HAD ENDOGRAFTS FROM DIFFERENT MANUFACTURERS. THERE WERE THREE PATIENTS THAT HAD ANCURE ENDOGRAFTS. TWO OF THOSE PATIENTS HAD A TYPE IA ENDOLEAK REQUIRING INTERVENTION; ONE PATIENT HAD AN OSC, BUT THE REASON WAS NOT PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE INTERVENTION. THE SPECIFIC MODEL AND SERIAL NUMBER INFORMATION WAS NOT PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112272 ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT) GRAFT MIH GUIDANT ENDOVASCULAR SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R