BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 9679634 · Received February 6, 2020

    Report

    Report Number
    2031527-2020-00035
    Event Type
    Death
    Date Received
    February 6, 2020
    Report Date
    January 8, 2020
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Removal / Correction Number
    Z-0006-2019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL ASSESSMENT WAS COMPLETED BASED ON THE RECEIVED MEDICAL RECORDS. DUE TO A LACK OF THE DEATH CERTIFICATE, EVENT COMPUTERIZED TOMOGRAPHY SCANS AND/OR DOCTORS NOTES THE REPORTED EVENTS OF URGENT PRESENTATION, RUPTURED AORTA, MISDIAGNOSED TYPE 3A ENDOLEAK AND THE PATIENT EXPIRING ARE UNCONFIRMED. DEVICE, USER, PROCEDURE OR ANATOMY RELATEDNESS OF THIS EVENT COULD NOT BE DETERMINED. HOWEVER, THE LAST 2 CT SCANS RECEIVED SHOWED A SIGNIFICANT INCREASED INFRARENAL ANGLE (AORTA REMODELING). MEDICAL INFORMATION WAS RECEIVED RELATED TO PRIOR EVENTS; CONFIRMED: EL IIIA WITH COMPLETE COMPONENT SEPARATION; SUCCESSFUL SECONDARY ENDOVASCULAR INTERVENTION, 65MONTHS POST IMPLANT. CONFIRMED: STENOSIS OF THE REIA AND SAC GROWTH BETWEEN 3 AND 65 MONTHS POST IMPLANT. THE MANUFACTURING LOT EVALUATION CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICE WAS NOT RETURNED AS THE DEVICE REMAINS IMPLANTED; THEREFORE, NO EVALUATION WAS COMPLETED. NO ADDITIONAL INVESTIGATION OF THIS REPORTED EVENT IS PLANNED HOWEVER IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ENDOLOGIX WILL CONTINUE TO MONITOR THIS COMPLAINT AND SIMILAR COMPLAINTS IN THE EVENT FURTHER INVESTIGATION IS NEEDED. DEVICE ITERATION IS AFX WITH STRATA. CORRECTIONS: H6: RESULT CODE: REMOVE CODE 3233. H6: CONCLUSION CODE: REMOVE CODE 11.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINED 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¿. DEVICE REMAINED IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    THE PATIENT WAS INITIALLY IMPLANTED WITH A BIFURCATED STENT GRAFT, A SUPRARENAL STENT GRAFT EXTENSION AND A LIMB STENT GRAFT EXTENSION TO TREAT AN ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 7.5 YEARS POST INITIAL PROCEDURE, THE PATIENT PRESENTED WITH A RUPTURED AORTA POSSIBLY FROM A MISDIAGNOSED 3A ENDOLEAK. THE PATIENT WAS BEING TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT, BUT WAS REPORTED TO HAVE EXPIRED DURING THE TRANSFER. THE DATE OF EVENT OR DEATH WAS NOT PROVIDED, BUT REPORTEDLY OCCURRED BETWEEN (B)(6) 2019 TO (B)(6) 2020. NO FURTHER INFORMATION WAS PROVIDED, BUT HAS BEEN REQUESTED. NOTE: THIS PATIENT HAD TWO (2) PREVIOUS REPORTED EVENTS. MFR REPORT #2031527-2017-00516 WAS FOR A TYPE 3A ENDOLEAK THAT WAS RESOLVED BY IMPLANTING A SUPRARENAL STENT GRAFT EXTENSION. MFR REPORT# 2031527-2017-00612 WAS FOR STENOSIS OF THE RIGHT EXTERNAL ILIAC ARTERY AND A NON ENDOLOGIX STENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140327 AFX BIFURCATED STENT GRAFT MIH ENDOLOGIX BA25-70/I16-30 W11-5737-005

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death LIMB EXTENSION, LOT #W11-6080-027| SUPRARENAL AORTIC EXTENSION, LOT# W11-6376-004| VELA, LOT#1719281004