BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3774624 · Received April 26, 2014

    Report

    Report Number
    2031527-2014-00124
    Event Type
    Malfunction
    Date Received
    April 26, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. THE PATIENT MEDICAL INFORMATION WAS REVIEWED BY CLINICAL COMPLAINT SPECIALIST WITH THE FOLLOWING INFORMATION: THE PATIENT'S HEALTH STATUS AND MEDICAL HISTORY MIGHT HAVE CONTRIBUTED TO THE COMPLICATION IN THE FORM OF DISEASE PROGRESSION. THERE MIGHT HAVE BEEN EVIDENCE OF AN ENDOLEAK; THERE WAS A REPORTED, BUT UNSUBSTANTIATED SECONDARY PROCEDURE TO RELINE THE STENT. 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 ALL UNITS WERE CONSUMED AND 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 ISSUES COULD NOT BE IDENTIFIED BECAUSE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS BUT THE INCIDENT DESCRIBED THE PATIENT'S HEALTH STATUS AND MEDICAL HISTORY WHICH MAY HAVE CONTRIBUTED TO ENDOLEAK 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 6 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A POSSIBLE ENDOLEAK. REPORTEDLY, THE CT SCAN IDENTIFIED POSSIBLE COMPONENT SEPARATION. COURSE OF TREATMENT, IF ANY, IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253063 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT (BGI) MIH ENDOLOGIX, INC. BA28-80/I16-40 W11-4123-011

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR