BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3782077 · Received April 30, 2014

    Report

    Report Number
    2031527-2014-00133
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE, NOT AVAILABLE FOR ANALYSIS. BASED UPON INVESTIGATION FINDINGS, THE REPORTED EVENT IS INCONCLUSIVE. NO PRODUCT WAS RETURNED FOR EVALUATION, AND NO CASE IMAGES OR MEDICAL RECORDS WERE RECEIVED. A MANUFACTURING RECORD REVIEW WAS PERFORMED, THE LOT MET ALL RELEASE CRITERIA WITH NO ISSUES OR DEVIATIONS THAT WOULD EXPLAIN THE REPORTED EVENT. THE LOT USAGE HISTORY SHOWED THAT NO OTHER UNITS FROM THE SAME LOT HAVE BEEN INVOLVED IN ANY SIMILAR EVENT. BASED UPON THE INVESTIGATION FINDINGS, A ROOT CAUSE FOR THE REPORTED ISSUES COULD NOT BE IDENTIFIED.

    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. DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS POST IMPLANT OF A BIFURCATED DEVICE, AN INFRARENAL AORTIC EXTENSION AND A LIMB EXTENSION; A FOLLOW-UP COMPUTED TOMOGRAPHY SCAN REVEALED A PROXIMAL ENDOLEAK. THE PATIENT WAS TREATED WITH AN INFRARENAL AORTIC EXTENSION, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260215 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION STENT GRAFT (SCI) MIH ENDOLOGIX, INC. 28-28-75L W09-0816-014

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention