BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AFX SYSTEM

    MDR report key: 3833738 · Received May 27, 2014

    Report

    Report Number
    2031527-2014-00164
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 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. IMAGING WAS PROVIDED AND REVIEWED BY A CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THERE MIGHT HAVE BEEN PRODUCT USE THAT WAS INCONGRUENT WITH IFU DUE TO THE ANEURYSMAL, THROMBIC, SHORT REVERSE CONICAL AORTIC NECK AND SEVERELY ANGLED LEFT ILIAC ARTERIES. THE STENT OCCLUSION WAS SUBSTANTIATED WITH AN ARTERIAL COMMUNICATION BETWEEN THE STENT GRAFT AND BOTH THE INFERIOR MESENTERIC ARTERY AND A RIGHT LUMBAR ARTERY. THE THROMBUS PROGRESSED OVERTIME AND THE ARTERIAL COMMUNICATION REMAINED PERSISTENT AT THIRTEEN MONTHS. THERE WAS NO EVIDENCE TO SUPPORT A MALFUNCTION, BUT RATHER THE POSSIBLE ARTERIAL COMMUNICATION (POSSIBLE TYPE II ENDOLEAK) MIGHT HAVE CONTRIBUTED TO THE EVENT. 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 HAVE BEEN 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 MOST LIKELY CAUSE FOR THE REPORTED EVENTS IS RELATED TO THE PATIENT'S VESSEL MORPHOLOGY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 13 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN IDENTIFIED CLOT IN THE BIFURCATED DEVICE. REPORTEDLY, THE DEVICE LUMEN HAD STILL FLOW. THE COURSE OF ACTION, IF ANY, HAS NOT BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310110 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA28-90/I20-30 1089144-007

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR