BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 4251528 · Received November 14, 2014

    Report

    Report Number
    2031527-2014-00326
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 15, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. MEDICAL RECORDS AND IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: PRODUCT APPROPRIATENESS COULD NOT BE FULLY ASSESSED DUE TO THE LACK OF A PRE-IMPLANT CT SCAN. AN ASSESSMENT OF THE PRE-IMPLANT ANGIOGRAM IMAGES WAS USED TO IDENTIFY PRODUCT USE THAT MIGHT HAVE BEEN INCONGRUENT WITH THE IFU. THESE FINDINGS INCLUDED: A SEVERELY CALCIFIED/STENOTIC RIGHT COMMON ILIAC ARTERY AND THE LEFT ILIAC ARTERY ANGULATION WAS GREATER THAN 90 DEGREES. THIS PATIENT'S MEDICAL HISTORY COUPLED WITH THE LONGEVITY OF THE DEVICE MIGHT HAVE CONTRIBUTED TO THIS EVENT AS AORTIC REMODELING; THERE WAS A REDUCTION OF OVERLAP AT 38 MONTHS POST IMPLANT, AND THE SUPRARENAL CUFF MIGHT HAVE MIGRATED SUPERIORLY, ADJACENT TO THE SUPERIOR MESENTERIC ARTERY (ITS POSITION COULD NOT BE ASSESSED IN THE IMPLANT ANGIOGRAM, DUE TO LACK OF IMAGES). AT 38 MONTHS POST IMPLANT THERE WAS SUBSTANTIATED EVIDENCE OF: THROMBUS OF THE CUFF AND MAIN BODY STENT; AND, AN OCCLUSIVE THROMBUS OF THE LEFT ILIAC STENT AND ARTERY. A SECONDARY PROCEDURE OF A FEMORAL-FEMORAL BYPASS WAS SUBSTANTIATED. THE FINAL DISPOSITION OF THE PATIENT WAS DISCHARGED HOME ON THE FIFTH POST OPERATIVE DAY. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED ALL UNITS HAVE BEEN CONSUMED AND 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 THE OCCLUSION IS MOST LIKELY RELATED TO THE PATIENT'S ANATOMY (GREATER THAN 90 DEGREE ANGULATION OF LEFT ILIAC), WHICH WAS INCONGRUENT WITH IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 38 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION THE PATIENT EXPERIENCED CHEST PAIN ON THE LEFT SIDE. A CT WAS PERFORMED AND SHOWED A LEFT OCCLUSION. THERE WAS AN ACUTE ANGLE IN THE LEFT COMMON ILIAC ARTERY THAT MAY HAVE CONTRIBUTED TO THE LIMB OCCLUSION. THE PHYSICIAN HAS ELECTED TO PERFORM A FEM-FEM BYPASS. THE ANEURYSM COMPLETELY REGRESSED AROUND THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738018 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA22-80/I13-40 W11-3107-006

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention