BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AFX SYSTEM

    MDR report key: 2880593 · Received December 19, 2012

    Report

    Report Number
    2031527-2012-00177
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    December 2, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Additional Manufacturer Narrative · 1

    BASED UPON THE REVIEW OF LOT RECORDS, WORK ORDERS, AND PRIOR REPORTS NO ISSUES WITH THE LOT WERE NOTED. ACTUAL DEVICE WAS NOT RETURNED HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, COMPUTED TOMOGRAPHIC SCANS AND ANGIOGRAM IMAGES WERE PROVIDED BY THE HOSPITAL AND WERE REVIEWED BY CLINICAL REPRESENTATIVE. BASED ON THE REVIEW OF THE ANGIOGRAM IMAGES FOR THE INDEX PROCEDURE INDICATES EXCLUSION OF THE ANEURYSM WITH GRAFT PATENCY AND NO ENDOLEAKS. ON FOLLOW-UP COMPUTED TOMOGRAPHIC SCANS POST-IMPLANT AND PRIOR TO SECONDARY PROCEDURE CONFIRMS THE IN-FOLDING. DEFINITE CAUSE IS UNKNOWN BUT LIKELY IT CAN BE DUE TO IMPROPER SIZING OR LACK OF POST DILATATION BALLOON MODELING OF THE STENT GRAFT. OCCLUSIONS ARE A KNOWN RISK OF THE PROCEDURE, AS IDENTIFIED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY EIGHT MONTHS POST IMPLANT OF AN INFRARENAL AORTIC EXTENSION, A BIFURCATED STENT GRAFT, AND A LIMB EXTENSION, THE PROXIMAL PORTION OF THE INFRARENAL AORTIC EXTENSION BECAME OCCLUDED. REPORTEDLY, THE PATIENT CAME TO THE EMERGENCY ROOM COMPLAINING OF LEG PAIN AND NUMBNESS. A COMPUTED TOMOGRAPHY SCAN REVEALED A SLIGHT IN-FOLDING AND OCCLUSION OF THE INFRARENAL AORTIC EXTENSION. AN AXILLO-FEMORAL BYPASS WAS PERFORMED TO RESTORE DISTAL BLOOD FLOW. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AFX SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. A25-25/C75 W11-4741-011

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention