BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3090818 · Received May 2, 2013

    Report

    Report Number
    2031527-2013-00082
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 22, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P04002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT HENCE DEVICE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS WERE REVIEWED BY A CLINICAL REPRESENTATIVE. THE REVIEW INDICATES THAT THE PROXIMAL INFRARENAL EXTENSION SHIFTED DOWN, AND THE DISTAL SECTION BECAME PARTIALLY DISLODGED FROM THE MAIN BODY, POSSIBLY FROM ANTERIOR FORCE DISPLACEMENT. THIS ISSUE WOULD ALLOW FOR THE REPORTED ENDOLEAK AND SUBSEQUENT CONTAINED RUPTURE. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO 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 EVENTS. 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. REMAINS IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY NINE MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND AN INFRARENAL AORTIC EXTENSION, A COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK AND A CONTAINED RUPTURE. REPORTEDLY, THE AORTIC EXTENSION MOVED DISTALLY CAUSING A PROXIMAL TYPE I ENDOLEAK. THE PATIENT WAS TREATED WITH A COMPETITOR'S STENT, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191608 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100 1032599-008

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention