BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3953577 · Received July 23, 2014

    Report

    Report Number
    2031527-2014-00209
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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: THERE WAS SUBOPTIMAL MEDICAL DOCUMENTATION AND IMAGING STUDIES AVAILABLE FOR THIS REVIEW. PRODUCT USE MIGHT HAVE BEEN INCONGRUENT TO THE IFU AND MIGHT HAVE CONTRIBUTED TO THE REPORTED EVENT DUE TO: IODINE ALLERGY, WHICH MIGHT HAVE DETERRED REGULAR, CONTRASTED SURVEILLANCE; AND ILIAC ARTERY DIAMETERS WERE GREATER THAN 23 MM. THE PATIENT'S USE OF ANTIPLATELET THERAPY INCREASED THEIR RISK FOR BLEEDING COMPLICATIONS, WHICH MIGHT HAVE CONTRIBUTED TO THE ADVERSE EVENT. AT INDEX, THE OVERLAP OF BOTH ILIAC COMPONENTS WAS ESTIMATED TO BE LESS THAN 15 MM, WHICH MOST LIKELY A CONTRIBUTING FACTOR. THERE WAS SUBSTANTIATING EVIDENCE OF: AN ENDOLEAK TYPE IIIA AND COMPONENT SEPARATION. THE SECONDARY PROCEDURE WAS SUBSTANTIATED BY MEDICAL RECORDS, BUT THE FINAL PATIENT DISPOSITION WAS NOT KNOWN DUE TO LACK OF INFORMATION. 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 WERE INVOLVED IN ANY SIMILAR EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING.

    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 19 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION. REPORTEDLY, A COMPUTED TOMOGRAPHY SCAN REVEALED AN ENDOLEAK DUE TO COMPONENT SEPARATION BETWEEN THE BIFURCATED DEVICE AND INFRARENAL AORTIC EXTENSION. THE PHYSICIAN TREATED THE PATIENT WITH TWO ADDITIONAL LIMB EXTENSIONS TO BRIDGE THE TWO COMPONENTS. THE REPAIR WAS SUCCESSFUL AND THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430327 AFX SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. I20-13/C88F SA 1040024-002

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention