BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3243949 · Received July 23, 2013

    Report

    Report Number
    2031527-2013-00168
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. CT IMAGES WERE PROVIDED AND REVIEWED BY A CLINICAL REPRESENTATIVE. BASED ON THE REVIEW OF THE IMAGES, IT APPEARS THAT THE PROXIMAL AORTIC EXTENSION DID NOT MAINTAIN SUFFICIENT AORTIC WALL APPOSITION OVER TIME, CAUSING THE REPORTED LEAK. IN THIS CASE THE ROOT CAUSE OF THE ENDOLEAK CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES AND DEVIATIONS THAT EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWS THAT NO OTHER UNITS FROM THIS LOT HAVE BEEN INVOLVED IN SIMILAR EVENTS AT THIS TIME.. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. CORRECTED DATA: DESCRIBE EVENT OR PROBLEM; CONTACT OFFICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 24 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION A COMPUTED TOMOGRAPHY SCAN IDENTIFIED A TYPE I ENDOLEAK BETWEEN THE SUPRARENAL AORTIC EXTENSION AND BIFURCATED DEVICE. THE PATIENT WAS TREATED WITH A SUPRARENAL AORTIC EXTENSION WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 24 MONTHS POST IMPLANT OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION A COMPUTED TOMOGRAPHY SCAN IDENTIFIED A TYPE IA ENDOLEAK BETWEEN THE SUPRARENAL AORTIC EXTENSION AND RENAL ARTERIES. THE PATIENT WAS TREATED WITH A SUPRARENAL AORTIC EXTENSION WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342637 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A28-28/C75-O20 W11-4099R-022

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention