BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX2

    MDR report key: 11486514 · Received March 15, 2021

    Report

    Report Number
    2031527-2021-00135
    Event Type
    Death
    Date Received
    March 15, 2021
    Date of Event
    February 19, 2021
    Report Date
    February 19, 2021
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009014399
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 RUPTURE EVENT REPORTED IS UNCONFIRMED. THIS IS NOT CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE MOST LIKELY CAUSATION FOR THE REPORTED EVENT IS INDETERMINATE. PROCEDURE RELATED HARMS, DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS COMPLAINT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. 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 AFX2. CORRECTIONS: B3: DATE OF EVENT-DATE HAS BEEN UPDATED G2: CONTACT OFFICE- NAME HAS BEEN UPDATED 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 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 AFX2.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX2 BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB STENT GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY 4 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH ANEURYSM RUPTURE AND SENT TO THE EMERGENCY ROOM. THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383638 AFX2 BIFURCATED STENT GRAFT MIH ENDOLOGIX BEA28-120/I20-40 1590565022 00818009014399

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death AFX LIMB STENT GRAFT - 1265066006| AFX LIMB STENT GRAFT - 1612277008| AFX VELA SUPRARENAL - 1669575003| AFX LIMB STENT GRAFT - 1265066006| AFX LIMB STENT GRAFT - 1612277008| AFX VELA SUPRARENAL - 1669575003