BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 7800890 · Received August 21, 2018

    Report

    Report Number
    2031527-2018-00676
    Event Type
    Injury
    Date Received
    August 21, 2018
    Date of Event
    August 6, 2018
    Report Date
    August 6, 2018
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE COMPLETION OF THE CLINICAL EVALUATION AND BASED ON THE INFORMATION RECEIVED, THERE WAS SUBSTANTIAL EVIDENCE TO SUPPORT THE FOLLOWING REPORTED EVENT: TYPE IB ENDOLEAK FROM THE MAIN BODY LEFT COMMON ILIAC ARTERY. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED BASED ON THE INFORMATION SHARED WITH ENDOLOGIX TO REVIEW. PROCEDURE RELATED HARMS FOR THIS COMPLAINT COULD NOT BE DETERMINED BASED ON THE INFORMATION SHARED WITH ENDOLOGIX TO REVIEW. THE FINAL PATIENT STATUS WAS REPORTED TO BE DOING WELL POST SECONDARY ENDOVASCULAR PROCEDURE. THE MANUFACTURING LOT REVIEW CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THIS COMPLAINT IS NOT CAPA ELIGIBLE AT THIS TIME. THESE TYPES OF EVENTS WILL BE MONITORED AND TRENDED AS PART OF THE QUALITY SYSTEM. ADDITIONAL INFORMATION: CODE: ADD 3331, 4112. CORRECTION: CONCOMITANT MEDICAL PRODUCT: REMOVE W11-4123-023 AND ADD W11-5786-003; REMOVE RESULT CODE 3233 AND ADD 4247; REMOVE CONCLUSION CODE 11 AND ADD 22, 4315.

    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 ON (B)(6) 2012. APPROXIMATELY SIX (6) YEARS POST INITIAL PROCEDURE, ANEURYSM GROWTH WAS DETECTED IN THE LEFT COMMON ILIAC WITH A TYPE IB ENDOLEAK ON (B)(6) 2018. ENDOLOGIX BECAME AWARE OF THE REPORTED ADVERSE EVENT AND PRODUCT PROBLEM ON (B)(6) 2018. THE PHYSICIAN ELECTED TO TREAT THE PATIENT BY IMPLANTING TWO OVATION IX EXTENDER DEVICES ON (B)(6) 2018. THE PATIENT WAS REPORTED TO BE DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641655 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX BA28-80/I16-40 W11-4123-023

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention AFX-BIFURCATED STENT GRAFT-LN W11-4123-023.| AFX-LIMB EXTENSION:W11-5786-003.| AFX-SUPRARENAL AORTIC EXTENSION-LN W11-3729R-025.| AFX-BIFURCATED STENT GRAFT-LN W11-4123-023| AFX-SUPRARENAL AORTIC EXTENSION-LN W11-3729R-025