BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3090823 · Received May 2, 2013

    Report

    Report Number
    2031527-2013-00083
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P04002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY SEVENTY-THREE MONTHS POST IMPLANT OF A BIFURCATED DEVICE, INFRARENAL AORTIC EXTENSION, AND TWO LIMB EXTENSIONS, THE PATIENT PRESENTED WITH A TYPE II ENDOLEAK AND THE PHYSICIAN CHOSE TO EXPLANT THE DEVICES. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192366 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 28-28-75L W07-0336-004

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention