BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCURE ENDOGRAFT

    MDR report key: 1369325 · Received April 24, 2009

    Report

    Report Number
    2954310-2009-81713
    Event Type
    Injury
    Date Received
    April 24, 2009
    Report Date
    April 23, 2009
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO IDENTIFY PATIENT'S AND/OR MODEL-SERIAL NUMBERS WERE UNSUCCESSFUL.

    Description of Event or Problem · 1

    EVENT WAS CREATED BY A JOURNAL ARTICLE WHICH WAS RECEIVED ON MARCH 27, 2009. ARTICLE CITATION: PURANDATH LALL, MBBS, PETER GLOVICZKI, MD, GAUTAM AGARWAL, MBBS, AUDRA A. DUNCAN, MD, MANJU KALRA, MBBS, TANYA HOSKIN, MS, GUSTAVO S. ODERICH, MD, AND THOMAS C BOWER, MD. COMPARISON OF EVAR AND OPEN REPAIR IN PATIENTS WITH SMALL ABDOMINAL AORTIC ANEURYSMS: CAN WE PREDICT RESULTS OF THE TRIAL? JOURNAL OF VASCULAR SURGERY, 2009; 49 (1):52-9. THERE WERE PATIENTS WHO UNDERWENT ELECTIVE ENDOVASCULAR REPAIR (EVAR) FOR 4.0-5.0 CM AAA AT A SINGLE CENTER BETWEEN 1997 AND 2004. OF THESE PATIENTS, SOME WERE IMPLANTED WITH AN ANCURE/EVT ENDOGRAFT. COMPLICATIONS OBSERVED INCLUDE: TYPE I AND II ENDOLEAKS. EARLY MORBIDITY INCLUDED CONGESTIVE HEART FAILURE, ARRHYTHMIA, NON ST ELEVATION MI. LATE RESULTS INCLUDED INCREASED ANEURYSM SAC SIZE, AND GROIN LYMPHOCELE. RE-INTERVENTION WAS PERFORMED DUE TO ENDOLEAKS, EMBOLI, AND LYMPHOCELE EXCISION. THREE LATE DEATHS IN THIS GROUP WERE NOTED, BUT CAUSE OF DEATH WAS NOT CONFIRMED BY AUTOPSY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R