BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 12002866 · Received June 15, 2021

    Report

    Report Number
    2031527-2021-00237
    Event Type
    Death
    Date Received
    June 15, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 1, 2021
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    UDI-DI
    00818009013552
    PMA / PMN Number
    P040002
    Removal / Correction Number
    Z-0008-2019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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 3A ENDOLEAK OF THE AORTIC COMPONENTS IS CONFIRMED. THIS IS CONSISTENT WITH THE REPORTED ADVERSE EVENT/INCIDENT. THE CLINICAL EVALUATION ALSO SHOWS REASONABLE EVIDENCE TO SUGGEST A TYPE 3B ENDOLEAK OF THE BIFURCATED STENT GRAFT, SAC GROWTH OF 23MM AND AN AORTIC RUPTURE HAD ALSO OCCURRED. THE MOST LIKELY CAUSATION FOR THE REPORTED EVENT IS USER-RELATED DUE TO THE OFF-LABEL CONCOMITANT PRODUCT USE OF A NON-ENDOLOGIX DEVICE DURING THE PREVIOUS RE-INTERVENTION IN 2020. PROCEDURE-RELATED HARMS OF THIS EVENT COULD NOT BE DETERMINED WITH THE MEDICAL RECORDS AVAILABLE FOR REVIEW. THE FINAL PATIENT STATUS WAS REPORTED AS BEING DECEASED. 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 DURAPLY CORRECTIONS: B5 DESCRIBE EVENT OR PROBLEM . G4 AWARENESS DATE . H6 DEVICE CODES (AS EVALUATED); REMOVE 3190. H6 EVALUATION RESULT CODES; REMOVE 3233. H6 EVALUATION CONCLUSION CODES; REMOVE 11.

    Description of Event or Problem · 0

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL STENT GRAFT. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL DUE TO A TYPE 3A ENDOLEAK. A RE-INTERVENTION WAS COMPLETED THE FOLLOWING DAY. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL AFX VELA INFRARENAL STENT GRAFT AT THE SEPARATION HOWEVER THE PROXIMAL EDGE OF THE NEW VELA DID NOT FULLY APPOSE; THEREFORE, AN ADDITIONAL NON-ENDOLOGIX STENT GRAFT (EXCLUDER) WAS IMPLANTED WITH SUCCESS. THE PATIENT WAS STABLE POST-PROCEDURE (MFR REPORT# 2031527-2020-00148). APPROXIMATELY (1) ONE YEAR POST-RE-INTERVENTION THE PATIENT ENTERED INTO A SHOCK STATE RESULTING FROM A TYPE 3A ENDOLEAK. AN (EVAR) ENDOVASCULAR ANEURYSM REPAIR WAS PERFORMED AND A NON-ENDOLOGIX STENT GRAFT (EXCLUDER) PROXIMAL EXTENSION WAS ADDITIONALLY ADDED TO THE INSIDE OF THE EXISTING STENT-GRAFTS, THERE WAS NO INCREASE IN THE BLOOD PRESSURE AND THE PATIENT¿S CONDITION DID NOT IMPROVE WITH THEM REMAINING IN A SHOCK STATE. THE PATIENT EXPIRED ON THE SAME DAY. ADDITION INFORMATION: THE CLINICAL ASSESSMENT DETERMINED THAT THERE WAS EVIDENCE TO SUGGEST A TYPE 3B ENDOLEAK OF THE BIFURCATED STENT GRAFT, SAC GROWTH OF 23MM AND AN AORTIC RUPTURE HAD ALSO OCCURRED.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IT WILL NOT BE RETURNED FOR EVALUATION. 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 DURAPLY.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY TREATED FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WITH THE IMPLANT OF AN AFX2 BIFURCATED STENT GRAFT AND AN AFX VELA SUPRARENAL STENT GRAFT. APPROXIMATELY TWO (2) YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL DUE TO A TYPE 3A ENDOLEAK. A RE-INTERVENTION WAS COMPLETED THE FOLLOWING DAY. THE PHYSICIAN ELECTED TO IMPLANT AN ADDITIONAL AFX VELA INFRARENAL STENT GRAFT AT THE SEPARATION HOWEVER THE PROXIMAL EDGE OF THE NEW VELA DID NOT FULLY APPOSE; THEREFORE, AN ADDITIONAL NON-ENDOLOGIX STENT GRAFT (EXCLUDER) WAS IMPLANTED WITH SUCCESS. THE PATIENT WAS STABLE POST-PROCEDURE (MFR REPORT# 2031527-2020-00148). APPROXIMATELY (1) ONE YEAR POST-RE-INTERVENTION THE PATIENT ENTERED INTO A SHOCK STATE RESULTING FROM A TYPE 3A ENDOLEAK. AN (EVAR) ENDOVASCULAR ANEURYSM REPAIR WAS PERFORMED AND A NON-ENDOLOGIX STENT GRAFT (EXCLUDER) PROXIMAL EXTENSION WAS ADDITIONALLY ADDED TO THE INSIDE OF THE EXISTING STENT-GRAFTS, THERE WAS NO INCREASE IN THE BLOOD PRESSURE AND THE PATIENT¿S CONDITION DID NOT IMPROVE WITH THEM REMAINING IN A SHOCK STATE. THE PATIENT EXPIRED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899636 AFX VELA INFRARENAL MIH ENDOLOGIX A34-34/C100V 2250155-016 00818009013552

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death AFX VELA SUPRARENAL 1728932011| AFX2 BIFURCATED STENT GRAFT 1751374002| AFX VELA SUPRARENAL 1728932011| AFX2 BIFURCATED STENT GRAFT 1751374002