BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 12229641 · Received July 27, 2021

    Report

    Report Number
    2031527-2021-00284
    Event Type
    Injury
    Date Received
    July 27, 2021
    Date of Event
    July 12, 2021
    Report Date
    July 12, 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
    NJ, 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 REQUIRED TO BE RETURNED TO ENDOLOGIX FOR EVALUATION BECAUSE THE ISSUE HAS ALREADY IDENTIFIED WITH STRATA MATERIAL AND WAS UPDATED TO DURAPLY. 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 TYPE 3B ENDOLEAK WAS NOT UNCONFIRMED. THE OPEN REPAIR COMPLAINT IS CONFIRMED. THIS IS MODERATELY CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE MOST LIKELY CAUSATION FOR THE REPORTED EVENT IS DEVICE-RELATED DUE TO THE USE OF STRATA MATERIAL. PROCEDURE RELATED HARMS OF THIS EVENT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. THE FINAL PATIENT STATUS WAS REPORTED TO BE DOING WELL. 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 JULY 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: G4: DATE RECEIVED BY MANUFACTURER HAS BEEN UPDATED H6: RESULT CODE: REMOVE CODE 3233 H6: CONCLUSION CODE: REMOVE CODE 11.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX BIFURCATED STENT GRAFT, AFX SUPRARENAL AORTIC EXTENSION, AND AN AFX LIMB STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY (8) EIGHT YEARS POST INITIAL PROCEDURE THE PATIENT WAS PRESENTED WITH A TYPE 3B ENDOLEAK. THE PHYSICIAN ELECTED TO PERFORM A RE-INTERVENTION AND EXPLANT THE DEVICE. THE PATIENT'S STATUS WAS REPORTED AS DOING WELL FOWLING THE SECONDARY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1127074 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX BA28-100/I16-40 1047129-022

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention AFX LIMB STENT GRAFT 1039903-029| AFX SUPRARENAL AORTIC EXTENSION 1026334-027| AFX LIMB STENT GRAFT 1039903-029| AFX SUPRARENAL AORTIC EXTENSION 1026334-027