BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3953506 · Received July 23, 2014

    Report

    Report Number
    2031527-2014-00215
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. SUBOPTIMAL MEDICAL DOCUMENTATION AND IMAGING STUDIES WERE PROVIDED AND REVIEWED BY A CLINICAL REPRESENTATIVE WITH THE FOLLOWING IMPRESSION: THERE WERE NO DYNAMIC IMAGES PROVIDED TO CORROBORATE THE REPORTED ENDOLEAK, OR ITS SUCCESSFUL TREATMENT. HOWEVER, THERE WAS MENTION IN THE MEDICAL DOCUMENTATION OF THE CALCIFICATIONS WITHIN THE AORTIC NECK AS THE CAUSE OF THE TEAR/BLUSHING. THE MEDICAL DOCUMENTATION DID NOT INCLUDE THE SPECIFIC AREA, OR WHICH STENT WAS INVOLVED IN THE FRANK ENDOLEAK /TEAR/BLUSHING. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED NO OTHER UNITS 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. THE IFU UNDER WARNINGS AND PRECAUTIONS STATES: IRREGULAR CALCIFICATION AND/OR PLAQUE MAY COMPROMISE GRAFT INTEGRITY OR THE FIXATION AND SEALING OF THE IMPLANTATION SITES.

    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 DURING IMPLANTATION OF A BIFURCATED DEVICE AND A SUPRARENAL AORTIC EXTENSION, A COMPUTED TOMOGRAPHY SCAN REVEALED BLUSHING COMING FROM WHAT APPEARED A TEAR OF THE AORTIC EXTENSION. REPORTEDLY, A HARD PIECE OF CALCIUM HAD BEEN OBSERVED AT THE LOCATION OF THE ALLEGED TEAR/BLUSHING. THE PHYSICIAN ELECTED TO RELINE THE AORTIC EXTENSION WITH AN ADDITIONAL AORTIC EXTENSION. REPEAT CT SHOWED THE BLUSHING WAS NO LONGER PRESENT. THE PATIENT WAS REPORTED TO BE DOING WELL POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430921 AFX SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A34-34/C100-O20V 1246593-007

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention