BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 2086505 · Received May 3, 2011

    Report

    Report Number
    2954310-2011-81793
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    February 1, 2010
    Report Date
    May 3, 2011
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO FIND OUT THE SPECIFIC MODEL/SERIAL NUMBERS FOR THE ARTICLES THAT WERE NOT PREVIOUSLY REPORTED. HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. AT THIS TIME, NO ADDITIONAL INFO HAS BEEN REPORTED. THE FINDINGS OF THIS STUDY IS SUMMARIZED IN THE ARTICLE: HOBBS ET AL., "EPIDEMIOLOGY AND DIAGNOSIS OF ENDOGRAFT INFECTION," J. CARDIOVASCULAR SURGERY 2010; 51: 5-14.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMERLY GUIDANT) RECEIVED INFO THAT THIS LITERATURE REVIEW JOURNAL ARTICLE REVEALED PTS WITH ENDOGRAFT INFECTIONS PRESENT SYMPTOMS IN THREE SPECIFIC WAYS: AORTOENTERIC FISTULA, NON-SPECIFIC SIGNS OF LOW GRADE SEPSIS, AND SEVERE SYSTEMIC SEPSIS. ENDOGRAFT INFECTION IS REPORTED TO OCCUR IN BETWEEN (B)(6) OF PTS. THE ARTICLE PROVIDED SEVERAL REFERENCES TO OTHER ARTICLES WHERE INFECTIONS WITH ANCURE/EVT ENDOGRAFTS HAD OCCURRED. FURTHER INVESTIGATIONS INTO THESE SPECIFIC REFERENCES FOUND THAT THE INFECTIONS PRESENTED WITHIN 3 TO 11 MONTHS POST IMPLANT. SEVERAL OF THE ARTICLES LISTED WERE PREVIOUSLY REPORTED TO THE FOOD AND DRUG ADMINISTRATION (2954310-2008-81662, 2954310-2007-81629, AND 2954310-2009-81714). THE OTHER ARTICLES REFERENCED WERE FROM STUDIES BACK IN 2002 TO 2003. IN THE ARTICLES NOT PREVIOUSLY REPORTED, ANTIBIOTIC ADMINISTRATION AND SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE ENDOGRAFT AND TREAT THE PT. THERE WAS ONE PT DEATH REPORTED BUT THE CAUSE OF DEATH WAS DEEMED TO BE DUE TO RESPIRATORY FAILURE AND WAS NOT CAUSED BY THE ENDOGRAFT INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R