BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3222199 · Received July 12, 2013

    Report

    Report Number
    2031527-2013-00165
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT, HENCE NO DEVICE EVALUATION WAS PERFORMED. HOWEVER, COMPUTED TOMOGRAPHY IMAGING POST INDEX PROCEDURE WERE PROVIDED FOR CLINICAL ASSESSMENT. BASED ON THE REVIEW, THE REPORT OF DISTAL ENDOLEAK TYPE I WAS CONFIRMED IN THE LEFT ILIAC ARTERY. AVAILABLE IMAGING SHOWS TORTUOUS ANATOMY AND LEFT ILIAC CALCIFICATION. THE LIKELY CAUSE OF THE ENDOLEAK APPEARS TO BE RELATED TO THE VESSEL TORTUOSITY AND CALCIFICATION. REVIEW OF THE MANUFACTURING RECORDS DID NOT INDICATE THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE, AND ARE IDENTIFIED IN THE PRODUCT LABELING UNDER POTENTIAL ADVERSE EVENTS.

    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 APPROXIMATELY 2 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, A SUPRARENAL AORTIC EXTENSION AND TWO LIMB EXTENSIONS, A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED A DISTAL TYPE 1 ENDOLEAK ON THE LEFT LIMB. THE PATIENT WAS TREATED 3 MONTHS LATER WITH AN ADDITIONAL LIMB EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324121 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL 1062538-002

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention