BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3861888 · Received November 7, 2013

    Report

    Report Number
    2031527-2013-00262
    Event Type
    Injury
    Date Received
    November 7, 2013
    Date of Event
    October 9, 2013
    Report Date
    October 9, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE INVESTIGATION FINDINGS, THE REPORTED EVENT IS INCONCLUSIVE. A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, SIZING SHEET WAS REVIEWED AND INDICATED THAT THE PATIENT PRESENTED WITH REVERSED CONICAL NECK, WHICH MAY HAVE CONTRIBUTED TO THE MISPLACEMENT OF SUPRARENAL AORTIC EXTENSION AND SUBSEQUENT PROXIMAL TYPE I ENDOLEAK. A MANUFACTURING RECORD REVIEW WAS PERFORMED. THE LOTS MET ALL RELEASE CRITERIA WITH NO RELATED NCMRS. THE LOT USAGE HISTORY SHOWS THAT NO OTHER UNITS FROM THIS LOT HAVE BEEN INVOLVED IN ANY SIMILAR COMPLAINTS AT THIS TIME. THE PRODUCT FMEAS HAVE BEEN REVIEWED AND CONFIRMED THAT THE RISK HAS BEEN ACCURATELY CAPTURED. THE PRODUCT LABELING HAS BEEN REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, INFRARENAL AORTIC EXTENSION, AND A SUPRARENAL AORTIC EXTENSION, A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK OF A SUPRARENAL EXTENSION. THE PATIENT WAS TREATED WITH AN ADDITIONAL SUPRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL. ACCORDING TO THE SALES REPRESENTATIVE THE PHYSICIAN PLACED THE FIRST SUPRARENAL AORTIC EXTENSION TOO LOW, INTRA-OPERATIVELY WITH NO ENDOLEAK. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577485 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C80-O20 1046989-014

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention