BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3181016 · Received June 20, 2013

    Report

    Report Number
    2031527-2013-00156
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED FOR EVALUATION. STILL CT IMAGES WERE PROVIDED AND REVIEWED BY CLINICAL SPECIALIST. BASED ON REVIEW OF THE INFORMATION THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. HOWEVER, IT APPEARS THAT THE PATIENT'S ANATOMY MAY HAVE BEEN A FACTOR. A MANUFACTURING RECORD REVIEW WAS PERFORMED AND THE LOT MET ALL RELEASE CRITERIA WITH NO RELATED ISSUES THAT WOULD EXPLAIN THE REPORTED EVENT. THE PRODUCT LABELING WAS REVIEWED AND CONFIRMED THAT THE REPORTED EVENT IS ADEQUATELY CAPTURED IN THE EXISTING LABELING. THE LOT USAGE HISTORY SHOWS THAT NO OTHER UNITS FROM THIS LOT HAVE BEEN INVOLVED IN SIMILAR EVENT. (B)(4).

    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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INDEX PROCEDURE THE PHYSICIAN WAS UNABLE TO ADVANCE THE BIFURCATED DEVICE THROUGH THE LEFT ILIAC ARTERY. REPORTEDLY, THE PATIENT PRESENTED WITH SYMPTOMATIC ANEURYSM, SHORT NECK, SEVERE ANGULATION WITH CALCIFIED PLAQUE AND TORTUOUS VESSELS. THE PHYSICIAN REMOVED BOTH THE BIFURCATED DEVICE AND THE INTRODUCER SHEATH. A SECOND BIFURCATED DEVICE AND INTRODUCER SHEATH WAS USED AND THE PHYSICIAN EXPERIENCED THE SAME ISSUE. SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE SECOND BIFURCATED DEVICE, BUT WERE UNSUCCESSFUL IN DOING SO. THE BIFURCATED DEVICE AND THE INTRODUCER SYSTEMS WERE BOTH REMOVED AGAIN. DURING THE REMOVAL OF THE DEVICE, THE PATIENT¿S EXTERNAL ILIAC WAS TORN. A STIFF WIRE WAS PLACED ALL THE WAY UP TO THE AORTA AND THE PHYSICIAN ADVANCED THE THIRD INTRODUCER SHEATH AND AN ADDITIONAL BIFURCATED DEVICE AND WAS ABLE TO SUCCESSFULLY DEPLOY THE STENT GRAFT. THE PHYSICIAN THEN PERFORMED AN INTERNAL CONDUIT WITH A LIMB EXTENSION AND A COMPETITOR¿S STENT GRAFT AND BALLOONED INTO THE LEFT ILIAC ARTERY TO CONTROL THE BLEEDING. THE PHYSICIAN COMPLETED THE PROCEDURE BY IMPLANTING A SUPRARENAL AORTIC EXTENSION. A FINAL ANGIOGRAM WAS PERFORMED AND IDENTIFIED THE SUPRARENAL AORTIC EXTENSION SHIFTED DISTALLY TO THE BIFURCATED STENT GRAFT, WHICH RESULTED IN A DISTAL TYPE I ENDOLEAK. THE PATIENT WAS TREATED WITH A COMPETITOR¿S STENT GRAFT, AN INFRARENAL AORTIC EXTENSION, AND AN ADDITIONAL SUPRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280578 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-100/I16-40 1050785-002

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention