BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1822962 · Received September 1, 2010

    Report

    Report Number
    2031527-2010-00108
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 26, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. THE PHYSICIAN DID NOT WANT TO SACRIFICE BOTH HYPOGASTRIC ARTERIES IN THE SAME PROCEDURE.

    Description of Event or Problem · 1

    ON (B)(6) 2009, IMPLANT OF A 25-16-140BL BIFURCATED DEVICE, A 25-25-75L PROXIMAL EXTENSION, AND A 16-16-88L LIMB EXTENSION ON THE LEFT. A SLIGHT DISTAL TYPE I ENDOLEAK WAS LEFT ON THE RIGHT; HOWEVER, THE PHYSICIAN DID NOT WANT TO SACRIFICE BOTH HYPOGASTRICS AT THE SAME TIME. THE PATIENT WAS BROUGHT BACK ON (B)(6) 2010 AND WAS TREATED WITH A 16-16-88L ON THE RIGHT, WHICH RESOLVED THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-140BL W09-2982-002

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention