BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX SYSTEM

    MDR report key: 3150733 · Received June 6, 2013

    Report

    Report Number
    2031527-2013-00125
    Event Type
    Death
    Date Received
    June 6, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 10, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, IMAGES WERE REVIEWED BY THE MEDICAL DIRECTOR. BASED ON THE REVIEW OF IMAGES RIGHT ILIAC CALCIFICATION EXTENDING INTO THE EXTERNAL ILIAC ARTERY WAS NOTED. THE MOST LIKELY REASON FOR THE THROMBOSIS IS PROGRESSIVE DISEASE. BASED ON THE REVIEW OF THE EVENT, INFORMATION AVAILABLE, MANUFACTURING RECORDS, AND COMPLAINT HANDLING DATABASE, THERE IS NO EVIDENCE THAT THIS EVENT IS DUE TO A MANUFACTURING ISSUE. OCCLUSION IS A KNOWN RISK, AS IDENTIFIED IN THE PRODUCT LABELING.

    Additional Manufacturer Narrative · 1

    REVIEW OF PATHOLOGY REPORT WAS PERFORMED BY MEDICAL DIRECTOR. THE REVIEW CONCLUDES THAT THE CAUSE OF PATIENT DEATH WAS RELATED TO THE COMPLICATIONS OF THE FEMORAL-FEMORAL BYPASS WHERE HEMORRHAGIC SHOCK WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 13 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION THE PATIENT PRESENTED IN THE EMERGENCY ROOM COMPLAINING OF LEG PAIN. A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED THE LEFT LIMB OF THE BIFURCATED DEVICE WAS OCCLUDED. THE PHYSICIAN ATTEMPTED TO RE-CANNULATE THE LIMB, BUT WAS UNSUCCESSFUL. THEREFORE, THE PATIENT WAS TREATED WITH A FEMORAL-FEMORAL BYPASS. IT WAS REPORTED THE PATIENT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250054 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-90/I16-30 1030221-001

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death