BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3855084 · Received June 9, 2014

    Report

    Report Number
    2031527-2014-00174
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. THERE WERE SUBOPTIMAL MEDICAL IMAGES AND DOCUMENTATION AVAILABLE FOR THIS REVIEW. PRODUCT USE MIGHT HAVE BEEN INCONGRUENT WITH THE IFU AND MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT: ANGLED NECK GREATER THAN 60 DEGREES (NOTE: THE SIZING SHEET DENOTES THE NECK TO BE MILD-MODERATE ANGLE); LARGE MURAL THROMBUS, AND THE PRESENCE OF THROMBUS WITHIN THE THORACIC AND INFRARENAL AORTA. THIS PATIENT HAD MANY RISK FACTORS FOR THROMBOEMBOLISM THAT MIGHT HAVE CONTRIBUTED TO THIS COMPLAINT: AGE, RHEUMATOID ARTHRITIS, HISTORY OF CANCER, CURRENT SMOKER. ONE-MONTH POST INDEX, THE PATIENT SUFFERED A TIA. THERE MIGHT HAVE BEEN EVIDENCE OF A TRANSIENT ENDOLEAK AT INDEX. THERE WAS A COMPLICATION OF LOW BACK PAIN WITH A SIX-WEEK DURATION THAT REQUIRED AN ADMISSION, THREE MONTHS POST INDEX. IN RETROSPECT, THIS ADMISSION MIGHT HAVE BEEN TELLING OF AN EMBOLIC CONDITION RATHER THAN, OR IN ADDITION TO THE DIAGNOSIS OF OSTEOPOROSIS. THERE WAS SUBSTANTIATING EVIDENCE OF A MAIN BODY PARTIAL OCCLUSION AT SIX MONTHS POST INDEX. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE COULD NOT BE CONCLUSIVELY IDENTIFIED; HOWEVER, THE PATIENT'S PRE-EXISTING CONDITIONS ARE LIKELY CONTRIBUTING FACTORS. 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 THAT NO OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 20.6 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN IDENTIFIED APPROXIMATELY 8MM OF CLOT IN THE AORTIC EXTENSION. REPORTEDLY, THE DEVICE LUMEN HAD STILL FLOW. THE PHYSICIAN IS MONITORING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334896 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100-O20 1054959-021

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR