BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX

    MDR report key: 10426523 · Received August 19, 2020

    Report

    Report Number
    2031527-2020-00239
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 22, 2020
    Report Date
    July 27, 2020
    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
    AZ, 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. 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 THE TYPE 3B ENDOLEAK OF THE BIFURCATED STENT GRAFT EVENT IS CONFIRMED WITH THE PROCEDURE PLANNING IMAGES REVIEWED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE CLINICAL EVALUATION ALSO SHOWS REASONABLE EVIDENCE TO SUGGEST CONCOMITANT USE OF NON-ENDOLOGIX (COOK ZENITH RENU GRAFTS). PROCEDURE RELATED HARMS, DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS EVENT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. THE MOST LIKELY CAUSATION OF THE 3B ENDOLEAK IS THE USE OF THE STRATA MATERIAL. DURING THE INVESTIGATION. ENDOLOGIX FOUND REASONABLE EVIDENCE TO SUGGEST THE DEVICE WAS USED OFF-LABEL DUE TO THE CONCOMITANT USE WITH NON-ENDOLOGIX PRODUCTS OUTSIDE THE IFU (COOK ZENITH GRAFTS). THE FINAL PATIENT STATUS REMAINS UNKNOWN. THE FINAL PATIENT STATUS WAS NOT MADE AVAILABLE TO ENDOLOGIX. 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; UPGRADED GRAFT MATERIAL (I.E. DURAPLY) AND 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.

    Description of Event or Problem · 0

    THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE THE PATIENT WAS IDENTIFIED WITH A 3B ENDOLEAK DURING A ROUTINE FOLLOW UP. THE PATIENT IS PENDING RE-INTERVENTION. ADDITIONAL INFORMATION: CLINICAL ASSESSMENT IDENTIFIED OFF LABEL USE OF NON-ENDOLOGIX (COOK ZENITH) DEVICE. THIS PROCEDURE IS OUTSIDE THE INDICATIONS OF USE (OFF- LABEL) DUE TO CONCOMITANT USE WITH PRODUCTS OUTSIDE THE IFU.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE 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 A BIFURCATED STENT GRAFT AND A SUPRARENAL STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 6 YEARS POST INITIAL PROCEDURE THE PATIENT WAS IDENTIFIED WITH A 3B ENDOLEAK DURING A ROUTINE FOLLOW UP. THE PATIENT IS PENDING RE-INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893522 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX BA25-110/I20-30 1250330-021

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other VELA SUPRARENAL, LOT # 1246593008| VELA SUPRARENAL, LOT # 1246593008