BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 2993751 · Received March 7, 2013

    Report

    Report Number
    2031527-2013-00051
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 4, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, IMAGES WERE REVIEWED BY MEDICAL DIRECTOR INDICATING THAT ENDOLEAK MAY HAVE BEEN CAUSED DUE TO INADEQUATE APPOSITION LEADING TO AORTIC EXPANSION. THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. REVIEW OF LOT RECORDS, WORK ORDERS, AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. BASED UPON THE INVESTIGATION FINDINGS, THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE, AS IDENTIFIED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THIRTEEN MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, THE PATIENT PRESENTED WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, THE PATIENT PRESENTED IN EMERGENCY ROOM WITH ABDOMINAL PAIN. THE PHYSICIAN BELIEVES THAT THERE MIGHT BE A TYPE III ENDOLEAK OF BIFURCATED DEVICE. THE PHYSICIAN ELECTED TO USE A COMPETITOR'S STENT GRAFT TO ADDRESS THE TYPE III ENDOLEAK. DURING RELINING THE STENT GRAFT, THE PHYSICIAN NOTED A TYPE II ENDOLEAK. THE PATIENT WAS TREATED WITH A TRANSLUMBAR TO EMBOLIZE AN ILIO-LUMBAR VESSEL, WHICH SUCCESSFULLY CORRECTED THE TYPE II ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98178 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-100/I16-40 W11-3343-017

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention