BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 7520441 · Received May 16, 2018

    Report

    Report Number
    2031527-2018-00453
    Event Type
    Injury
    Date Received
    May 16, 2018
    Date of Event
    January 1, 2017
    Report Date
    March 29, 2018
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING RECORD REVIEW AND LOT HISTORY COULD NOT BE COMPLETED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED THEREFORE NO EVALUATION WAS COMPLETED. DUE TO THE LACK OF INFORMATION PROVIDED, ENDOLOGIX IS UNABLE TO CONFIRM OR DETERMINE THE CAUSE OF THE REPORTED EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT DENIED. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX CONTINUES TO INVESTIGATE THIS EVENT AND SIMILAR EVENTS TO ENSURE THE HIGHEST QUALITY AND PATIENT SAFETY.

    Description of Event or Problem · 1

    ENDOLOGIX WAS NOTIFIED BY M2S INC. (VASCULAR QUALITY INITIATIVE) FROM A LETTER DATED (B)(6) 2018 OF A PATIENT WITH A TYPE IIIB ENDOLEAK OF THE AORTIC COMPONENTS THAT WAS IMPLANTED IN 2017. IT WAS STATED THAT AN ADDITIONAL AFX BIFURCATED GRAFT WAS USED TO RELINE THE PREVIOUS GRAFT TO RESOLVE THIS ENDOLEAK. AS VASCULAR QUALITY INITIATIVE'S HOSPITALS ARE ANONYMOUS, NO PATIENT OR DETAILED PRODUCT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363258 AFX MAIN BODY-BIFURCATED STENT GRAFT MIH ENDOLOGIX INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention