BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 2873166 · Received December 13, 2012

    Report

    Report Number
    2031527-2012-00175
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT RETURNED, HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, AORTOGRAM RUNS, CTA IMAGES, AND CT REPORT WERE RECEIVED AND REVIEWED BY A CLINICAL REPRESENTATIVE. BASED ON THE REVIEW OF THE IMAGES AND REPORT, THE REPORTED TYPE III ENDOLEAK BETWEEN THE BIFURCATED DEVICE AND THE LEFT LIMB EXTENSION WAS CONFIRMED. BASED ON THE REVIEW OF THE MEDICAL RECORDS, IT WAS DETERMINED THAT THE PATIENT'S ANATOMY MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE REPORTED EVENT, DUE TO HIGHLY ANGULATED LEFT COMMON ILIAC ARTERY AND ANGULATED AORTA. THE MANUFACTURING RECORD REVIEW DID NOT REVEAL ANY ISSUES OR DEVIATION THAT WOULD EXPLAIN THE REPORTED EVENT. THE PRODUCTION LOTS MET ALL REQUIREMENTS PRIOR TO RELEASE, WITH NO NONCONFORMING MATERIAL RECORDS ASSOCIATED TO THE INVOLVED LOT. BASED ON THE REVIEW OF THE EVENT, INFORMATION AVAILABLE, MANUFACTURING RECORDS, AND PREVIOUS COMPLAINTS, THERE IS NO EVIDENCE THAT THIS COMPLAINT IS DUE TO A MANUFACTURING ISSUE. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE AND ARE IDENTIFIED IN THE PRODUCT LABELING, UNDER POTENTIAL ADVERSE EVENTS. ADDITIONALLY, THE DEVICE INSTRUCTIONS FOR USE UNDER WARNINGS STATES: VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST-IMPLANT OF A SUPRARENAL AORTIC EXTENSION, A BIFURCATED DEVICE, AND TWO LIMB EXTENSIONS, A TYPE III ENDOLEAK BETWEEN THE BIFURCATED DEVICE AND THE LEFT LIMB EXTENSION WAS IDENTIFIED ON A COMPUTED TOMOGRAPHY SCAN. REPORTEDLY, THE PATIENT WAS TREATED WITH TWO COMPETITOR STENT GRAFTS, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK ON THE LEFT SIDE; HOWEVER A SLIGHT DISTAL TYPE I ENDOLEAK WAS NOTED ON THE RIGHT SIDE. THE PATIENT WAS SCHEDULED FOR REPAIR OF THE RIGHT DISTAL TYPE I ENDOLEAK APPROXIMATELY 21 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. IS20-25/C55 1026514-007

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention