BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 7396768 · Received April 4, 2018

    Report

    Report Number
    2031527-2018-00214
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    March 5, 2018
    Report Date
    April 12, 2018
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    UPON FURTHER REVIEW, MFR. REPORT # 2031527-2018-00214 SENT ON 04 APR 2018 DESCRIBES A DUPLICATE EVENT. PLEASE REFERENCE MFR. REPORT # 2031527-2018-00227 WITH PATIENT (B)(6) FOR THE REPORTED DETAILS; THIS REPORT WAS ALSO SENT ON 04 APR 2018. PLEASE DISREGARD DUPLICATE MFR. REPORT # 2031527-2018-00214 WITH PATIENT (B)(6).

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AND REMAIN IMPLANTED IN THE PATIENT. IF ADDITIONAL INFORMATION IS OBTAINED AT A LATER TIME THAT IS PERTINENT TO THIS EVENT, A FOLLOW-UP REPORT WILL THEN BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A TWO (2) LIMB STENT GRAFTS ON (B)(6) 2013. THE SECONDARY CASE FOR THIS PATIENT WAS COMPLETED ON (B)(6) 2018 FOR AN UNKNOWN REASON AND THE PATIENT WAS IMPLANTED WITH TWO (2) AFX LIMB STENT GRAFTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238894 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX INC. BA28-100/I16-40 1053305-002

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other AFX-BIFURCATED STENT GRAFT - LOT 1053305002| AFX-LIMB STENT GRAFT - LOT 1047366020| AFX-LIMB STENT GRAFT - LOT 1047367009| AFX-BIFURCATED STENT GRAFT - LOT 1053305002| AFX-LIMB STENT GRAFT - LOT 1047366020| AFX-LIMB STENT GRAFT - LOT 1047367009