BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 3222244 · Received July 12, 2013

    Report

    Report Number
    2031527-2013-00140
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    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, MEDICAL RECORDS, WITHOUT PROCEDURAL IMAGES, WERE PROVIDED AND WERE REVIEWED BY A MEDICAL DIRECTOR. BASED ON REVIEW OF THE AVAILABLE REPORTS, THERE WAS CONSIDERABLE DIFFICULTY IN ACCURATE DEVICE DEPLOYMENT. DUE TO LACK OF PROCEDURE IMAGES, IT WAS NOT POSSIBLE TO EXPLAIN THE CAUSE OF THESE DIFFICULTIES, WHICH ARE POSSIBLY MORE OPERATOR RELATED THAN ANY DEVICE MALFUNCTION. THE REVIEW OF LOT RECORDS, WORK ORDERS, AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. BASED UPON THE INVESTIGATION FINDINGS, THE ROOT CAUSE OF THE REPORTED DEPLOYMENT DIFFICULTIES COULD NOT BE CONCLUSIVELY DETERMINED WITH AVAILABLE INFORMATION.

    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. REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY IN DEPLOYING THE IPSILATERAL LIMB OF THE BIFURCATED DEVICE. REPORTEDLY, WHILE DEPLOYING THE IPSILATERAL LIMB THE ENTIRE GRAFT STARTED PULLING ON THE CONTRALATERAL SIDE. THE PHYSICIAN HAD NO DIFFICULTY DEPLOYING THE CONTRALATERAL LIMB. ADDITIONALLY, THE PHYSICIAN HAD A BALLOON STENT ON THE CONTRALATERAL SIDE WHILE ATTEMPTING TO DEPLOY THE IPSILATERAL LIMB. IT WAS NOTICED AT THIS POINT THAT THE CONTRALATERAL LIMB LOOKED TWISTED. THE PHYSICIAN ELECTED TO IMPLANT A SUPRARENAL AORTIC EXTENSION. AN ANGIOGRAM SHOWED THE RIGHT COMMON ILIAC ARTERY DID NOT SEAL AND WAS FLOATING IN THE ANEURYSM. THE PHYSICIAN ATTEMPTED TO ADVANCE THE LIMB EXTENSION IN THE RIGHT COMMON ILIAC ARTERY, BUT WAS UNSUCCESSFUL. THE PHYSICIAN ELECTED TO PLACE AN INFRARENAL AORTIC EXTENSION IN THE MAIN BODY OF THE BIFURCATED DEVICE EXTENDING DOWN INTO THE LEFT LIMB TURNING THE GRAFT INTO AN AORTO-UNI-ILIAC (AUI) AND THEN PERFORMED A FEMORAL-FEMORAL BYPASS TO RE-VASCULARIZE THE RIGHT ILIAC ARTERY. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322697 AFX SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. BA25-100/I16-40 1047102-016

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention