BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3081636 · Received April 29, 2013

    Report

    Report Number
    2031527-2013-00090
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE WAS NOT RETURNED, HENCE NO DEVICE EVALUATION WAS PERFORMED. MEDICAL RECORDS AND INTRA OPERATIVE IMAGES WERE PROVIDED AND REVIEWED BY THE MANUFACTURER MEDICAL DIRECTOR. BASED ON THE REVIEW OF THE MEDICAL RECORDS, IT WAS DETERMINED THAT PROCEDURAL CONTEXT WERE A CONTRIBUTORY FACTOR TO THE REPORTED DEVICE COMPONENT DISPLACEMENT THAT RESULTED IN A PERSISTENT DISTAL TYPE III ENDOLEAK. REVIEW OF THE MANUFACTURING RECORDS INDICATES THE LOT MET ALL RELEASE CRITERIA WITH NO RELEVANT NONCONFORMING MATERIAL RECORDS. THE LOT USAGE HISTORY SHOWS THAT NO OTHER UNITS FROM THIS LOT HAVE BEEN INVOLVED IN ANY SIMILAR COMPLAINTS AT THIS TIME. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE, AS IDENTIFIED IN THE PRODUCT LABELING UNDER POTENTIAL ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF BIFURCATED DEVICE, FENESTRATED CUFF, INFRARENAL AORTIC EXTENSION, TWO RENAL STENT GRAFTS, AND A LIMB EXTENSION AN ANGIOGRAM REVEALED A TYPE III ENDOLEAK BETWEEN THE LIMB EXTENSION AND THE BIFURCATED DEVICE. IT WAS REPORTED THAT DURING PIGTAIL/CODA BALLOON EXCHANGE THE RIGHT LIMB OF THE BIFURCATED DEVICE WAS COMPROMISED AND PUSHED OVER TOWARD THE LEFT SIDE. SEVERAL ATTEMPTS WERE MADE TO REALIGN THE RIGHT LIMB OF THE BIFURCATED DEVICE, BUT WERE UNSUCCESSFUL. THE PHYSICIAN PLACED AN ADDITIONAL LIMB EXTENSION AND A PALMAZ STENT WHICH SIGNIFICANTLY REDUCED THE TYPE III ENDOLEAK, BUT STILL PRESENT. THE PHYSICIAN CHOSE TO CLOSE PROCEDURE AND MONITOR PATIENT. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185065 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-110/I20-30 1098686-016

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention