BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3965239 · Received July 29, 2014

    Report

    Report Number
    2031527-2014-00244
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 25, 2014
    Report Date
    July 25, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    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

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. MEDICAL RECORDS AND COMPUTER TOMOGRAPHY IMAGING WERE PROVIDED AND REVIEWED BY AN INTERNAL CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: PRODUCT USE WAS CONGRUENT WITH THE IFU; HOWEVER, THERE WERE OTHER CAUTIONARY CONDITIONS THAT MIGHT HAVE CONTRIBUTED TO THE REPORTED ISSUES SUCH AS: CONCENTRIC CALCIFICATIONS AND THROMBUS WITHIN THE AORTIC NECK. THERE WAS SUBSTANTIATED EVIDENCE OF: AN INTRAOPERATIVE STENT MIGRATION OF THE INFRARENAL AORTIC EXTENSION, AND AN ENDOLEAK TYPE IIIA. 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 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. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED ISSUE APPEARS TO BE RELATED TO CONDITIONS EXPERIENCED DURING USE, BASED ON THE REPORT THAT THE BIFURCATED MAIN BODY WAS DEPLOYED TOO CLOSE TO THE DISTAL AORTIC NECK, WHICH APPARENTLY CAUSED THE STENT MIGRATION AND RESULTING ENDOLEAK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM PROCEDURE, COMPONENTS SEPARATION OCCURRED RESULTING IN AN ENDOLEAK. REPORTEDLY, THE BIFURCATED MAIN BODY WAS DEPLOYED TOO CLOSE TO THE DISTAL AORTIC NECK. THE INFRARENAL AORTIC EXTENSION CAME OUT OF THE AORTIC NECK CAUSING THE COMPONENT SEPARATION. THE PHYSICIAN IMPLANTED A COMPETITORS BALLOON EXPANDABLE STENT TO BRIDGE THE COMPONENTS, WHICH RESOLVED THE ENDOLEAK. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442370 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A28-28/C75 V 1164395-004

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention