BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4090806 · Received September 15, 2014

    Report

    Report Number
    2031527-2014-00283
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. MEDICAL RECORDS AND IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THERE WAS ADEQUATE MEDICAL DOCUMENTATION AND IMAGING STUDIES AVAILABLE FOR THIS REVIEW. PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO: AORTIC NECK ANGLE GREATER THAN 60 DEGREES; AND, LEFT ILIAC ANGULATION GREATER THAN 90 DEGREES. CAUTIONARY PRODUCT USE CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT WERE: THE CUFF AND THE MAIN BODY WERE TWO SIZES LARGER THAN EACH OTHER. DISEASE PROGRESSION MIGHT HAVE CONTRIBUTED TO THE REPORTED OUTCOME DUE TO THE PATIENT'S CONTINUED TOBACCO USE. THERE WAS SUBSTANTIATED EVIDENCE OF: POST PROCEDURE STENT MIGRATION OF THE AORTIC CUFF EARLIER THAN REPORTED AT 15 MONTHS POST INDEX WITH THROMBUS SEEN WITHIN THE AORTIC EXTENSION AND BIFURCATED MAIN BODY. THERE WAS NO ASSOCIATED ENDOLEAK WITH THE MIGRATION; THERE WAS INTRAMURAL THROMBUS WITHIN BOTH THE AORTIC EXTENSION AND THE BIFURCATED STENT. THE SAC WAS STABLE, BUT THE INFRARENAL AORTA DIAMETER GREW FROM 23 MM TO 26 MM. THE SECONDARY PROCEDURE WAS CONFIRMED AND ITS OUTCOME SUCCESSFUL. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED NO OTHER UNITS WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED MIGRATION IS LIKELY FROM THE DIFFICULT ANATOMY AND OFF-LABEL USE OF THE DEVICES IDENTIFIED IN THE CLINICAL REVIEW. THE INVESTIGATION DID NOT IDENTIFY A DEVICE ISSUE.

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 27.5 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AND A SUPRARENAL AORTIC EXTENSIONS, A CT SCAN REVEALED DISTAL MIGRATION OF THE AORTIC EXTENSIONS. A PORTION OF THE AORTA, PROXIMAL TO THE RENALS, WAS NO LONGER COVERED. THE PHYSICIAN ELECTED TO BRING THE PATIENT BACK AND IMPLANTED AN INFRARENAL AND A SUPRARENAL AORTIC EXTENSION TO COVER THE GAP WITH SUCCESS. THE PATIENT IS DOING WELL. NOTE: THE PATIENT WAS REPORTED AT INITIAL IMPLANTATION WITH A VERY REVERSED TAPERED AORTIC NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568338 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100 1031713-005

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention