BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 8201182 · Received December 27, 2018

    Report

    Report Number
    2031527-2018-00967
    Event Type
    Injury
    Date Received
    December 27, 2018
    Report Date
    November 27, 2018
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009010261
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE COMPLETION OF THE CLINICAL ASSESSMENT, CLINICAL IDENTIFIED THAT BOTH THE 1A ENDOLEAK AND THE 3B ENDOLEAK WERE FROM THE BIFURCATED STENT GRAFT AND NOT THE INFRARENAL AORTIC EXTENSION AS PREVIOUSLY REPORTED. THE INVESTIGATION SUMMARY FOR THIS EVENT WILL BE RECORDED AND DOCUMENTED UNDER 2031527-2018-00971. WITH THIS NEW INFORMATION, THIS REPORTED IS NO LONGER NEEDED AND REQUESTING TO HAVE THIS REPORT 2031527-2018-00967 CANCELLED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: AT THE COMPLETION OF THE CLINICAL ASSESSMENT, CLINICAL IDENTIFIED THAT BOTH THE 1A ENDOLEAK AND THE 3B ENDOLEAK WERE FROM THE BIFURCATED STENT GRAFT AND NOT THE INFRARENAL AORTIC EXTENSION AS PREVIOUSLY REPORTED. THE INVESTIGATION SUMMARY FOR THIS EVENT WILL BE RECORDED AND DOCUMENTED UNDER 2031527-2018-00971. WITH THIS NEW INFORMATION, THIS REPORTED IS NO LONGER NEEDED AND REQUESTING TO HAVE THIS REPORT 2031527-2018-00967 CANCELLED.

    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 INITIALLY TREATED WITH THE AFX ABDOMINAL AORTIC ANEURYSM STENT. APPROXIMATELY THREE (3) YEARS POST INITIAL PROCEDURE, A TYPE IA ENDOLEAK WITH GROWTH IN THE NECK (ANEURYSM ENLARGEMENT) WAS DETECTED BY CT. THE PHYSICIAN PLANS TO RELINE WITH AN OVATION IX DEVICE AND RE-INTERVENTION IS SCHEDULED FOR (B)(6) 2019. THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040304 AFX INFRARENAL AORTIC EXTENSION MIH ENDOLOGIX A25-25/C55 1267817-004 00818009010261

    Patients

    Seq Age Sex Outcome Treatment
    1 Other AFX-BIFURCATED STENT GRAFT:1342797-004| AFX-LIMB STENT GRAFT:1336194-014| AFX-LIMB STENT GRAFT:1350055-005