BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3150883 · Received June 6, 2013

    Report

    Report Number
    2031527-2013-00147
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. (B)(4): REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY TWENTY-THREE MONTHS POST-IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION AND A SUPRARENAL AORTIC EXTENSION, A FOLLOW UP COMPUTED TOMOGRAPHY SCAN REVEALED AN ENDOLEAK. THE TYPE OF ENDOLEAK COULD NOT BE DETERMINED. REPORTEDLY, THE PHYSICIAN ELECTED TO PLACE A PALMAZ STENT AND AN INFRARENAL AORTIC EXTENSION, WHICH DID NOT CORRECT THE ENDOLEAK. THE PHYSICIAN ELECTED TO END THE PROCEDURE AND MONITOR THE PATIENT. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251293 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-120BL W11-0850-012

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention