BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 11921648 · Received June 2, 2021

    Report

    Report Number
    2031527-2021-00222
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    May 14, 2021
    Report Date
    May 14, 2021
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Removal / Correction Number
    Z-0006-2019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ADVERSE EVENT/INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH ENDOLOGIX OPERATING PROCEDURES AND WORK INSTRUCTIONS. WHERE POSSIBLE, IT IS ENDOLOGIX PRACTICE TO MAKE AT LEAST THREE GOOD FAITH EFFORTS TO RETRIEVE A REPORTED ADVERSE EVENT/INCIDENT RELATED DEVICE AS WELL AS MEDICAL RECORDS AND MEDICAL IMAGING. AN EVALUATION OF THE MANUFACTURING RECORD WAS COMPLETED. A REVIEW OF THE PART NUMBER/LOT NUMBER COMBINATION NEEDED FOR DEVICE IDENTIFICATION SHOWS THE DEVICE TO HAVE BEEN PROPERLY MANUFACTURED AND RELEASED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. THE REVIEW CONFIRMS THERE WERE NO MANUFACTURING OR PROCESSING NON-CONFORMITIES IDENTIFIED THAT WOULD CONTRIBUTE TO THE REPORTED ADVERSE EVENT/INCIDENT. AN EVALUATION OF THE DEVICE COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED TO ENDOLOGIX FOR EVALUATION BECAUSE IT REMAINS IMPLANTED. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THAT THE SAC GROWTH OF 7.5MM AND SECONDARY ENDOVASCULAR PROCEDURE ARE CONFIRMED. THE INDETERMINATE ENDOLEAK WAS FOUND TO BE A TYPE 3B ENDOLEAK OF THE DISTAL BIFURCATED STENT GRAFT. THIS IS MODERATELY CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE MOST LIKELY CAUSATION FOR THE TYPE 3B ENDOLEAK IS DEVICE RELATED DUE TO THE USE OF STRATA MATERIAL. THE FINAL PATIENT STATUS WAS REPORTED AS DOING WELL FOLLOWING SECONDARY ENDOVASCULAR PROCEDURE. A ROOT CAUSE INVESTIGATION WAS CARRIED OUT FOR ALL AFX COMPLAINTS HAVING AN IDENTIFIED FAILURE MODE OF A TYPE IIIB ENDOLEAK. ENDOLOGIX IMPLEMENTED THE FOLLOWING CORRECTIVE ACTIONS WITH THE INTENT OF REDUCING TYPE IIIB ENDOLEAK EVENTS; 1. UPGRADED GRAFT MATERIAL (I.E. DURAPLY) AND 2. UPDATES TO THE IFU AND ADDITIONAL PHYSICIAN TRAINING. THE CHANGE TO DURAPLY GRAFT MATERIAL AND THE IFU CHANGES WERE PUT IN PLACE (B)(6) 2014. NO ADDITIONAL INVESTIGATION OF THIS REPORTED ADVERSE EVENT/INCIDENT IS PLANNED. HOWEVER, SHOULD ADDITIONAL INFORMATION RELEVANT TO THE INVESTIGATION OUTCOME BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS AND SIMILAR ADVERSE EVENTS/INCIDENTS. DEVICE ITERATION IS AFX WITH STRATA. CORRECTIONS: B1: HAS BEEN UPDATED. B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENTS HAS BEEN UPDATED. B5: DESCRIBE EVENT OR PROBLEM HAS BEEN UPDATED. G4: DATE RECEIVED BY MANUFACTURER HAS BEEN UPDATED. H6: DEVICE CODE: REMOVE CODE 3190. H6: RESULT CODE: REMOVE CODE 3233. H6: CONCLUSION CODE: REMOVE CODE 11.

    Description of Event or Problem · 0

    THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (9) NINE YEARS POST INITIAL IMPLANT, SAC GROWTH AND AN ENDOLEAK (INDETERMINATE ORIGIN) WAS IDENTIFIED. REINTERVENTION HAS BEEN SCHEDULED. ADDITIONAL INFORMATION: PER INTERNAL INVESTIGATION, THE INDETERMINATE ENDOLEAK WAS FOUND TO BE A TYPE 3B ENDOLEAK OF THE DISTAL BIFURCATED STENT GRAFT. A SECONDARY PROCEDURE WAS COMPLETED. THE PHYSICIAN ELECTED TO IMPLANT AN AFX2 BIFURCATED STENT GRAFT AND AN INFRARENAL AORTIC EXTENSION TO RESOLVE THIS EVENT. THE PATIENT WAS REPORTED AS DOING FINE POST SECONDARY PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PATIENT MEDICAL RECORDS AND IMAGING STUDIES WILL BE REQUESTED FOR FURTHER EVALUATION BY THE CLINICAL SPECIALIST. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. DEVICE ITERATION IS AFX WITH STRATA.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT AND A SUPRARENAL AORTIC EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (9) NINE YEARS POST INITIAL IMPLANT, SAC GROWTH AND AN ENDOLEAK (OF INDETERMINATE ORIGIN) WERE IDENTIFIED AT ROUTINE SURVEILLANCE. REINTERVENTION HAS BEEN SCHEDULED. THE PATIENT IS REPORTEDLY ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822423 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX BA22-80/I13-40 W11-5097-010

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other| R AFX SUPRARENAL AORTIC EXTENSION (B)(4).| AFX SUPRARENAL AORTIC EXTENSION (B)(4).