BEUDAMED
    FDA Adverse Event Death Summary report: N

    AFX

    MDR report key: 12477622 · Received September 15, 2021

    Report

    Report Number
    2031527-2021-00346
    Event Type
    Death
    Date Received
    September 15, 2021
    Date of Event
    July 3, 2020
    Report Date
    July 6, 2020
    Manufacturer
    ENDOLOGIX
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF A JOURNAL ARTICLE PUBLISHED IN JULY 2020 IN THE JOURNAL OF VASCULAR SURGERY; TITLED "MIDTERM OUTCOMES FOR 605 PATIENTS RECEIVING ENDOLOGIX AFX OR AFX2 ENDOVASCULAR AAA SYSTEMS IN AN INTEGRATED HEALTHCARE SYSTEM" WHICH WAS RELATED TO AN ABSTRACT PUBLISHED IN OCTOBER 2019 IN THE JOURNAL OF AMERICAN COLLEGE OF SURGEONS; TITLED "RISK OF REINTERVENTION WITH ENDOLOGIX AFX ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM SYSTEMS IN A INTEGRATED HEALTH CASE SYSTEM" SUGGESTS A POSSIBLE ADDITIONAL 182 ADVERSE EVENTS THAT WERE NOT REPORTED TO ENDOLOGIX BY THE USER FACILITY. THESE 182 ADVERSE EVENTS WERE CAPTURED WITHIN NINETY-EIGHT (98) MEDICAL DEVICE REPORTS (MDR) THAT WERE PREVIOUSLY REPORTED BY ENDOLOGIX. IN SEPTEMBER 2021, A RETROSPECTIVE REVIEW OF THE JOURNAL ARTICLE PUBLISHED IN JULY 2020 WAS COMPLETED. AN ADDITIONAL 120 ADVERSE EVENTS WERE IDENTIFIED. THESE 120 ADVERSE EVENTS WILL BE CAPTURED WITHIN AN ADDITIONAL SIXTY-SEVEN (67) MEDICAL DEVICE REPORTS (MDR) TO BE FILED. ENDOLOGIX ATTEMPT TO GAIN FURTHER INFORMATION (E.G. TO RECONCILE POSSIBLE DISPARITIES/ERRORS BETWEEN QUANTITIES WITHIN THE NARRATIVE TABLES AND ASSOCIATED WITH THE KAPLAN MEIER CURVES) FROM THE PRIMARY AUTHOR BUT WAS DENIED. THIS MEDICAL DEVICE REPORT (MDR) REPRESENTS ONE OF THE SIXTY-SEVEN (1/67) ADDITIONAL REPORTS NEEDED. THIS REPORT IS FOR AN AAA-RELATED DEATH (DUE TO AN UNKNOWN REASON). THE REPORTED ADVERSE EVENT/INCIDENT WAS INVESTIGATED IN ALIGNMENT WITH ENDOLOGIX OPERATING PROCEDURES AND WORK INSTRUCTIONS. THE REPORTED ADVERSE EVENT/INCIDENT WAS IDENTIFIED BY ENDOLOGIX THROUGH AN ONGOING REVIEW OF INDUSTRY RELEVANT JOURNAL ARTICLES WHERE PATIENT RELATED OUTCOMES ARE PRESENTED ANONYMOUSLY, AND PATIENT SPECIFIC DEVICE INFORMATION IS UNAVAILABLE AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE COMPLETED. THE PART NUMBER/LOT NUMBER COMBINATION NEEDED FOR DEVICE IDENTIFICATION REMAINS UNKNOWN. AN EVALUATION OF THE DEVICE COULD NOT BE COMPLETED. THE DEVICE WAS NOT RETURNED TO ENDOLOGIX FOR AN EVALUATION. A CLINICAL EVALUATION OF THE ADVERSE EVENT/INCIDENT COULD NOT BE COMPLETED. NO MEDICAL RECORDS NOR MEDICAL IMAGING RELEVANT TO THE REPORTED ADVERSE EVENT/INCIDENT WAS RECEIVED BY ENDOLOGIX. DUE TO THE ABSENCE OF MEDICAL RECORDS AND MEDICAL IMAGING; DEVICE, USE, PROCEDURE, AND/OR ANATOMY RELATEDNESS TO THIS ADVERSE EVENT/INCIDENT COULD NOT BE EVALUATED. 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/INCIDENT DEVICE ITERATION IS AFX WITH STRATA. LITERATURE CITATION(S): DOI:HTTPS://DOI.ORG/10.1016/J.JVS.2020.06.048, DOI: HTTPS://DOI.ORG/10.1016/J.JAMCOLLSURG.2019.08.731. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    PUBLISHED ON 03JUL2020, IN THE JOURNAL OF VASCULAR SURGERY (JOURNAL PRE-PROOF 04JUN2020), JOURNAL ARTICLE, CLINICAL RESEARCH STUDY ABDOMINAL AORTIC AND ILIAC ARTERY ANEURYSMS/ VOLUME 73, ISSUE 3, P856-866, 01MAR2021. TITLED "MIDTERM OUTCOMES FOR 605 PATIENTS RECEIVING ENDOLOGIX AFX OR AFX2 ENDOVASCULAR AAA SYSTEMS IN AN INTEGRATED HEALTHCARE SYSTEM." THE PATIENT WAS INITIALLY IMPLANTED WITH AN AFX STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) ON AN UNKNOWN DATE. AN AAA-RELATED DEATH (DUE TO AN UNKNOWN REASON) WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THESE REPORTED EVENTS WERE FOUND DURING A PUBLICATION REVIEW WHERE THE PATIENT INFORMATION IS ANONYMOUS AND SPECIFIC DEVICE INFORMATION FOR INDIVIDUAL PATIENTS WAS NOT PROVIDED. LITERATURE CITATION(S): DOI:HTTPS://DOI.ORG/10.1016/J.JVS.2020.06.048, DOI: HTTPS://DOI.ORG/10.1016/J.JAMCOLLSURG.2019.08.731.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375094 AFX UNKNOWN MIH ENDOLOGIX

    Patients

    Seq Age Sex Outcome Treatment
    1 Death