BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 1696203 · Received May 20, 2010

    Report

    Report Number
    2954310-2010-81782
    Event Type
    Death
    Date Received
    May 20, 2010
    Date of Event
    January 30, 2010
    Report Date
    April 26, 2010
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM THE ARTICLE AUTHOR WAS UNSUCCESSFUL. THE FINDINGS OF THE STUDY WERE SUMMARIZED IN THE ARTICLE: STUART B. PRENNER, BS, IRENE C. TURNBULL, MD, RAJESH MALIK, MD, ALEXANDER SALLOUM, MD, SHARIF H. ELLOZY, MD, ANGELIKI G. VOUYOUKA, MD, MICHAEL L. MARIN, MD, AND PETER L. FARIES, MD, (B) (6) (J VASC SURG 2010) THIS ARTICLE IS STILL IN PRESS, THE COPYRIGHT DATE IS LISTED AS 1/30/2010.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (FORMERLY GUIDANT) RECEIVED INFORMATION FROM A STUDY DESIGNED TO EVALUATE OUTCOME OF ELECTIVE ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR IN OCTOGENARIANS AND NONAGENARIANS. THE STUDY INVOLVED 322 PTS. FOUR OF THE 322 PTS WERE IMPLANTED WITH THE ANCURE ENDOGRAFT. COMPARED TO OPEN REPAIR OF ABDOMINAL AORTIC ANEURYSMS (AAA), ENDOVASCULAR ANEURYSM REPAIR (EVAR) IS ASSOCIATED WITH DECREASED PERIOPERATIVE MORBIDITY AND MORTALITY. THIS STUDY SOUGHT TO EXAMINE THE OUTCOMES OF EVAR IN PTS GREATER THAN OR EQUAL TO (B) (4) YEARS OF AGE. DURING THE STUDY, REPORTED ADVERSE PT EFFECTS INCLUDED: 1 DEATH FROM MESENTERIC THROMBOSIS (CAUSE UNK), 4 DEATHS FROM CARDIAC COMPLICATION, 1 RESPIRATORY FAILURE, 1 INTERCRANIAL HEMORRHAGE, 1 SEPSIS (NON-GRAFT RELATED), 2 CARDIAC ARRESTS, 2 MIGRATIONS, 3 GRAFT THROMBOSES, 2 ENDOLEAKS (TYPE I), 1 VESSEL INJURY, 3 FAILURES OF CONTRALATERAL LIMB TO DEPLOY, 3 ISCHEMIC COLITIS, 2 COLECTOMIES, 2 MYOCARDIAL INFARCTIONS, 2 RENAL FAILURES, 1 TEMPORARY HEMODIALYSIS AND COIL EMBOLIZATION FOR TYPE II ENDOLEAKS. OVERALL, THERE WERE TOW INTRAOPERATIVE, ONE PERIOPERATIVE, AND FOUR LATE CONVERSIONS TO OPEN REPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| O| R