BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 2993771 · Received March 7, 2013

    Report

    Report Number
    2031527-2013-00050
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 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

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, MEDICAL RECORDS WERE REVIEWED BY A CLINICAL REPRESENTATIVE. BASED ON REVIEW OF MEDICAL RECORDS THE DISTAL TYPE 1 ENDOLEAK WAS CONFIRMED WHICH WAS RESOLVED WITH PLACEMENT OF A LIMB EXTENSION GRAFT. BASED ON AVAILABLE INFORMATION, A CAUSE CANNOT BE DETERMINED FOR THE TYPE 1 ENDOLEAK; HOWEVER, THERE IS NO INDICATION THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. BASED ON THE REVIEW OF THE EVENT, INFORMATION AVAILABLE, MANUFACTURING RECORDS, AND COMPLAINT HANDLING DATABASE, THERE IS NO EVIDENCE THAT THIS COMPLAINT IS DUE TO A MANUFACTURING ISSUE. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE AND ARE IDENTIFIED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SIXTEEN MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, SUPRARENAL AORTIC EXTENSION, AND A LIMB EXTENSION, A COMPUTED TOMOGRAPHY SCAN REVEALED A DISTAL TYPE I ENDOLEAK ON THE RIGHT COMMON ILIAC OF THE LIMB EXTENSION. REPORTEDLY, THE PATIENT WAS TREATED WITH AN ADDITIONAL LIMB EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96866 AFX SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. I20-20/C55F W11-4314-009

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention