BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 4372402 · Received December 30, 2014

    Report

    Report Number
    2031527-2014-00420
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Date of Event
    December 17, 2014
    Report Date
    December 17, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: ADEQUATE MEDICAL DOCUMENTATION AND SUBOPTIMAL IMAGING STUDIES WERE AVAILABLE FOR THIS REVIEW. PRODUCT USE WAS INCONGRUENT WITH THE IFU DUE TO THE 29% CHANGE IN THE AORTIC NECK DIAMETER AND GREATER THAN 90 DEGREE ANGULATION OF THE LEFT COMMON ILIAC ARTERY. CAUTIONARY PRODUCT USE CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THIS EVENT INCLUDED: BILATERAL ILIAC ARTERY TORTUOSITY AND THE MODERATE-SEVERE CALCIFICATIONS. INTRAOPERATIVELY, THERE WAS EVIDENCE TO SUPPORT A TYPE IA ENDOLEAK INTRA-OPERATIVE FOR WHICH AN ADDITIONAL VELA STENT WAS PLACED. ONE MONTH POST IMPLANT, THERE WAS EVIDENCE TO SUPPORT AN UNKNOWN ENDOLEAK; A DIFFERENTIAL DIAGNOSIS BETWEEN A TYPE IA OR II ENDOLEAK COULD NOT BE ESTABLISHED. THERE WAS NO EVIDENCE OF RENDERED TREATMENT. THE FINAL PATIENT DISPOSITION COULD NOT BE ESTABLISHED, BUT THE ANEURYSM SAC WAS NOTED TO BE DECREASING IN SIZE ON THE LAST KNOWN CT SCAN. REPORTEDLY, THE PATIENT IS STABLE. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED NO OTHER UNITS FROM THIS LOT 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, THE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION.

    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 1 MONTH POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, THE PATIENT WAS SEEN FOR A ROUTINE FOLLOW-UP. A COMPUTED TOMOGRAPHY SCAN REVEALED AN ENDOLEAK. THE PHYSICIAN HAS ELECTED TO WATCH THE PATIENT FOR A MONTH AND THEN PERFORM A SECONDARY INTERVENTION. THE PATIENT IS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859535 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C80-O20V 1250755-020

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR