BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 1567266 · Received December 23, 2009

    Report

    Report Number
    2954310-2009-81779
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    April 23, 2009
    Report Date
    December 21, 2009
    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

    ARTICLE CITATION: ALI F. ABURAHMA, MD, JOHN CAMPBELL, MD, PATRICK A. STONE, MD, ARVINDA NANJUNDAPPA, MD, AKHILESH JAIN, MD. L. SCOTT DEAN, PHD, MBA, JOSEPH HABIB, MD, TAMMI KEIFFER, RN, AND MARY EMMETT, PHD. IT IS LIKELY THAT MDR REPORTS WERE FILED AT THE TIME OF THE STUDY, HOWEVER, SINCE WE ARE UNABLE TO LINK PTS' NAMES OR MODEL SERIAL NUMBERS TO THE CLINICAL OBSERVATIONS, A MANUAL MEDWATCH REPORT WILL BE FILED FOR THIS ARTICLE. ATTEMPTS TO IDENTIFY PT'S AND OR MODEL-SERIAL NUMBERS TO THE CLINICAL OBSERVATIONS WERE UNSUCCESSFUL. NO ADD'L INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    THIS EVENT WAS CREATED FROM A JOURNAL ARTICLE IN THE JOURNAL OF VASCULAR SURGERY TITLED "THE CORRELATION OF AORTIC NECK LENGTH TO EARLY AND LATE OUTCOMES IN ENDOVASCULAR ANEURYSM REPAIR PTS" (J VASC SURG 2009; 50:738-48.) THIS ARTICLE ANALYZED ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURES IN 238 PTS, INCLUDING 49 ANCURE, TWO SPECIFIC ISSUES WERE NOTED WITH THE ANCURE ENDOGRAFT: ONE WAS SECONDARY TO FAILURE OF INTRODUCTION FOR THE ORIGINAL MODEL OF THE ANCURE DEVICE, WHICH WAS CONVERTED TO ANOTHER MFR'S DEVICE AND THE OTHER WAS DUE TO ILIAC ARTERY OBSTRUCTION/RUPTURE AND THE PT UNDERWENT OPEN REPAIR. CLINICAL OBSERVATIONS NOTED IN THE STUDY: PERIOPERATIVE DEATH, GROWTH OF ANEURYSM, ILIAC RUPTURE, STENT, PARALYSIS, MYOCARDIAL INFARCTION, DEATH, RENAL FAILURE, HEMATOMA, BLEEDING, INFECTION, COLON ISCHEMIA, SEPSIS, DEEP VEIN THROMBOSIS, SYSTEMIC EMBOLISM, AND ENDOLEAKS (TYPE I, II, III AND IV).

    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| R