BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3819459 · Received May 19, 2014

    Report

    Report Number
    2031527-2014-00159
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT IS CONFIRMED BASED ON CLINICAL ASSESSMENT OF CT IMAGES. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. MEDICAL RECORDS AND PROCEDURAL IMAGES WERE PROVIDED AND WERE REVIEWED BY A CLINICAL SPECIALIST WITH THE FOLLOWING IMPRESSION: THERE MIGHT HAVE BEEN PRODUCT USE THAT WAS INCONGRUENT WITH THE IFU DUE TO: THE MODERATELY SEVERE CALCIFICATION SEEN AT THE BIFURCATION AND LEFT ILIAC; THE IRREGULAR, ANGULATED BLOOD LUMEN AT THE AORTIC NECK; THE SAME DIAMETER OF A CUFF AND MAIN BODY STENT; AND, THE PRESENCE OF CHRONIC KIDNEY DYSFUNCTION BY WHICH CONTRAST SURVEILLANCE MIGHT NOT HAVE BEEN POSSIBLE. THERE WAS EVIDENCE OF LEFT ILIAC SHEATH INTRODUCER DIFFICULTIES. THERE WAS SUBSTANTIATED THROMBUS SEEN THROUGHOUT THE MAIN BODY AND LIMB STENT. OCCLUSIVE THROMBUS EXTENDED INTO THE LEFT ILIAC ARTERY. THERE WAS SUBSTANTIATING EVIDENCE OF STENT COLLAPSE OF THE MAIN BODY. A FEM-FEM BYPASS GRAFT AND ANTICOAGULATION THERAPY WERE COMPLETED. VASCULAR REPAIR WAS SUBSTANTIATED. 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, THE ROOT CAUSE IS DETERMINED TO BE RELATED TO THE PATIENT VESSEL MORPHOLOGY, WHICH MIGHT HAVE BEEN INCONGRUENT WITH IFU GUIDELINES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 11 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND SUPRARENAL AORTIC EXTENSION, AN OCCLUSION IN THE LIMB OF THE BIFURCATED WAS IDENTIFIED. A FOLLOW UP COMPUTED TOMOGRAPHY SCAN REVEALED THROMBUS IN THE LEFT LIMB, AND IN THE LUMEN OF THE GRAFT; ALSO IN THE THORACIC AORTA, WHICH MAY BE A CONTRIBUTING FACTOR. THE PHYSICIAN HAS NO PLAN OF ACTION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297199 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT (BGI) MIH ENDOLOGIX, INC. BA28-90/I16-30 1047074-012

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR