BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1933955 · Received December 21, 2010

    Report

    Report Number
    2031527-2010-00138
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. PATIENT ANATOMY DID MEET THE CRITERIA FOR INDICATIONS FOR USE. ENDOLEAKS ARE A KNOWN RISK OF THE PROCEDURE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH AN ANGLED NECK. PATIENT IMPLANT ON (B)(6) 2010 OF A (B)(4) BIFURCATED DEVICE, AND AN (B)(4) AORTIC EXTENSION. A 6 DAY POST OPERATIVE FOLLOW UP REVEALED A PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH A 25MM AORTIC EXTENSION AND AN AORTIC STENT TO CORRECT THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM SUPRARENAL PROXIMAL EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 28-28-115RL W10-1956-009

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention