BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT (FORMERLY EVT ENDOGRAFT)

    MDR report key: 1567265 · Received December 23, 2009

    Report

    Report Number
    2954310-2009-81780
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    June 8, 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: GREG C. SCHMIEDER, MD, CHRISTOPHER L. STOUT, MD, GORDON K. STOKES, MD, F. NOEL PARENT, MD, AND JEAN M. PANNETON, MD. IT IS LIKELY THAT MDR REPORTS WERE FILED AT THE TIME OF THE STUDY, HOWEVER, SINCE WE ARE UNABLE TO LINK PT 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 "ENDOLEAK AFTER ENDOVASCULAR ANEURYSM REPAIR: DUPLEX ULTRASOUND IMAGING IS BETTER THAN COMPUTED TOMOGRAPHY AT DETERMINING" (J VASC SURG 2009; 50: 1012-8.) CLINICAL OBSERVATIONS NOTED: 496 CONSECUTIVE PTS UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE OF WHICH 55 HAD AN ANCURE ENDOGRAFT. IMAGING STUDIES WERE OBTAINED IN 236 PTS, OF WHICH 202 (86%) WERE MALE. OVERALL, 137 ENDOLEAKS (29% OF PAIRED STUDIES) WERE DETECTED BY CT OR CDU SCAN. THERE WERE 8 TYPE I ENDOLEAKS, 123 TYPE II ENDOLEAKS, 4 TYPE III ENDOLEAKS, AND 2 INDETERMINATE ENDOLEAKS. EIGHTEEN PTS REQUIRED INTERVENTIONS FOR 19 ENDOLEAKS. ALL TYPE I AND III ENDOLEAKS WERE TREATED WITH ENDOVASCULAR CUFF OR LIMB EXTENSION PLACEMENT. THREE TYPE II ENDOLEAKS WERE TREATED WITH OPEN LIGATION, WHEREAS COIL OR GLUE EMBOLIZATION WAS USED IN EIGHT.

    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 Hospitalization| L| R