BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 3878081 · Received June 17, 2014

    Report

    Report Number
    2031527-2014-00180
    Event Type
    Death
    Date Received
    June 17, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 24, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INVESTIGATION CLINICAL ASSESSMENT, THE REPORTED EVENT WAS CONFIRMED. THERE WERE SUBOPTIMAL MEDICAL IMAGES AND DOCUMENTATION AVAILABLE FOR THIS REVIEW. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT NO OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED ISSUE WAS NOT SPECIFICALLY IDENTIFIED ALTHOUGH THE CLINICAL ASSESSMENT SUGGESTS THAT PATIENT CANDIDACY MIGHT HAVE BEEN INCONGRUENT WITH THE IFU DUE TO THE KNOWN CHRONIC KIDNEY INSUFFICIENCY, AND DIABETES AS WELL AS ANTICIPATED DIFFICULTY PRESENTED BY THE SEVERELY CALCIFIED AORTA AND BIFURCATION, BILATERAL STENTED ILIAC STENOSIS WITH CALCIFICATIONS, CALCIFIED INFRARENAL, AND A SOLITARY, INFLAMED KIDNEY. NO DEVICE ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWO WEEKS AGO POST IMPLANT OF A BIFURCATED DEVICE AND A INFRARENAL AORTIC EXTENSION A PEVAR (PERCUTANEOUS ENDOVASCULAR ANEURYSM REPAIR) WAS PERFORMED. THREE DAYS LATER THE PATIENT WAS BEING TAKEN TO THE OR DUE TO ISCHEMIC COLITIS OF THE SIGMOID COLON AND WOULD REQUIRE A COLOSTOMY. THIS WAS BELIEVED TO BE CAUSED FROM BLOCKING THE IMA (INFERIOR MESENTERIC ARTERY) WITH THE GRAFT. THE PATIENT EXPIRED TWO DAYS LATER DUE TO SEPSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356116 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-110/I16-30 1200663-011

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death