BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3081585 · Received April 29, 2013

    Report

    Report Number
    2031527-2013-00091
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 31, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    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 RETURNED TO ENDOLOGIX AND A SAMPLE EVALUATION WAS CONDUCTED, YET NO DEFINITE ROOT CAUSE COULD BE DETERMINED. FURTHERMORE, MEDICAL RECORDS WERE ALSO REVIEWED BY MEDICAL DIRECTOR AND IT WAS INDICATED THAT ISSUES WERE LIKELY THE RESULT OF HIGH RISK PATIENT WITH UNFAVORABLE ANATOMY. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-IMPLANT OF A BIFURCATED DEVICE AND SUPRARENAL AORTIC EXTENSION, THE PATIENT WAS CONVERTED TO OPEN REPAIR TO TREAT AN OCCLUSION IN THE RIGHT EXTERNAL ILIAC DISTAL TO THE BIFURCATED LIMB. REPORTEDLY, AFTER SUCCESSFUL IMPLANTATION OF THE BIFURCATED DEVICE AND SUPRARENAL AORTIC EXTENSION THE PATIENT DEVELOPED COLD LEG AND PAIN IN THE RIGHT LEG, PRESUMABLY RELATED TO AN OCCLUSION ON THE RIGHT SIDE. ADDITIONALLY, A COMPUTED TOMOGRAPHY SCAN REVEALED AN ENDOLEAK WHICH WAS SUBSEQUENTLY CONFIRMED AS TYPE II BY RADIOLOGIST. THE DEVICES WERE EXPLANTED AND THE PATIENT WAS TREATED WITH BILATERAL AXILLO-FEMORAL BYPASS. DURING CONVERSION THE SOURCE OF OCCLUSION WAS CONFIRMED AS BEING DISTAL TO THE BIFURCATED LIMB IN THE REGION OF THE RIGHT EXTERNAL ILIAC. REPORTEDLY, THE PATIENT TOLERATED THE CONVERSION PROCEDURE. ADDITIONAL INFORMATION: THE PATIENT HAD RESOLUTION OF RIGHT LEG ISCHEMIA AFTER OPEN CONVERSION, THOUGH WAS PARAPLEGIC POST-OP THEN WENT INTO MULTISYSTEM ORGAN FAILURE AND EXPIRED TWO DAYS LATER WHILE IN RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184589 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA22-90/I16-30 1047039-010

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention