BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 9175190 · Received October 10, 2019

    Report

    Report Number
    2031527-2019-00450
    Event Type
    Death
    Date Received
    October 10, 2019
    Date of Event
    September 9, 2019
    Report Date
    September 10, 2019
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Removal / Correction Number
    Z-0006-2019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. A LIMITED EVALUATION OF THE RETURNED DEVICE WAS COMPLETED AS DURING THE COMPLAINT INVESTIGATION, ENDOLOGIX IDENTIFIED EVIDENCE THAT THIS DEVICE WAS USED OUTSIDE THE INDICATIONS OF USE (OFF LABEL). EVALUATION OF THE REPORTED COMPLAINT INFORMATION ALONG WITH MEDICAL RECORDS, AND/OR MEDICAL IMAGING SUGGESTS THE CONDITIONS OF THE OFF LABEL HAS CAUSE THIS REPORTED EVENT. 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. A CLINICAL EVALUATION OF THE ADVERSE EVENT WAS COMPLETED. AN EXAMINATION OF MEDICAL RECORDS AND/OR MEDICAL IMAGING RECEIVED BY ENDOLOGIX SHOWS THAT THE REPORTED TYPE 1B ENDOLEAK WAS NOT CONFIRMED. HOWEVER, TYPE 3A ENDOLEAK WITH COMPLETE COMPONENT SEPARATION AND SAC GROWTH WERE CONFIRMED. THE MOST LIKELY CAUSATION OF THE TYPE 3A ENDOLEAK WAS MOST LIKELY RELATED TO THE OFF LABEL NECK ANGLE OF 70° (SHOULD BE LESS THAN 60°) AND THE SAC GROWTH IS RELATED TO THE TYPE 3A ENDOLEAK. AN OPEN REPAIR AND EXPLANT THE GRAFT WAS PERFORMED ON (B)(6) 2019. ON DAY TWO (2) POST INTERVENTION, THE PATIENT EXPERIENCED A MI (MYOCARDIAL INFARCTION). THE PATIENT WAS TRANSFERRED TO THE ICU AND PUT ON A VENTILATOR. THE PATIENT DID NOT FULLY RECOVER. THE PATIENT¿S FAMILY OPTED TO REMOVE ALL LIFE SUPPORT. IT IS PRESUMED THAT THE PATIENT EXPIRED SOON AFTER HOWEVER CONFIRMATION WAS NOT PROVIDED. 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. CORRECTIONS: B5: DESCRIBE EVENT OR PROBLEM HAS BEEN UPDATED. G1,2: CONTACT OFFICE- CONTACT HAS BEEN UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER HAS BEEN UPDATED. H6: METHOD CODE: REMOVE CODE 4117. 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 A BIFURCATED STENT GRAFT, AN INFRARENAL STENT GRAFT EXTENSION, A SUPRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WITH COMPLETE SEPARATION, SAC GROWTH AND A POSSIBLE 1B ENDOLEAK WAS IDENTIFIED. AN INTERVENTION IS BEING DISCUSSED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED. ADDITIONAL INFORMATION; AN INTERVENTION WAS COMPLETED ON (B)(6) 2019. THE PHYSICIAN ELECTED TO PERFORM AN OPEN REPAIR AND EXPLANT THE GRAFT. IT WAS REPORTED THAT THE PATIENT WAS DOING WELL. HOWEVER, ON DAY TWO (2) POST INTERVENTION, THE PATIENT EXPERIENCED A MI (MYOCARDIAL INFARCTION). THE PATIENT WAS TRANSFERRED TO THE ICU AND PUT ON A VENTILATOR. THE PATIENT DID NOT FULLY RECOVER. THE PATIENT¿S FAMILY OPTED TO REMOVE ALL LIFE SUPPORT. IT IS PRESUMED THAT THE PATIENT EXPIRED SOON AFTER HOWEVER CONFIRMATION WAS NOT PROVIDED.

    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, AN INFRARENAL STENT GRAFT EXTENSION, A SUPRARENAL STENT GRAFT EXTENSION AND TWO (2) LIMB GRAFT EXTENSIONS TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA). APPROXIMATELY SEVEN (7) YEARS POST INITIAL PROCEDURE, A TYPE 3A ENDOLEAK WITH COMPLETE SEPARATION, SAC GROWTH AND A POSSIBLE 1B ENDOLEAK WAS IDENTIFIED. AN INTERVENTION IS BEING DISCUSSED. AS OF THE DATE OF THIS REPORT, THERE HAVE BEEN NO ADDITIONAL PATIENT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    971504 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-100/I16-40 1033364-028

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death| O INFRARENAL AORTIC EXTENSION, LOT 1030854-003| LIMB EXTENSION, LOT 1030239-006| LIMB EXTENSION, LOT 1030239-009| SUPRARENAL AORTIC EXTENSION, LOT W11-4919-008