BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1722504 · Received June 14, 2010

    Report

    Report Number
    2031527-2010-00082
    Event Type
    Death
    Date Received
    June 14, 2010
    Report Date
    June 11, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF DEATH/DATE OF EVENT IS UNKNOWN.PATIENT WAS NOT TREATED AT PROCEDURE DATED (B) (6) 2010, DUE TO CALCIFICATION IN THE ILIAC VESSELS. DEVICE WOULD NOT TRACK THROUGH THE PATIENT'S ILIAC VESSELS AND AAA WAS NOT TREATED. IT WAS REPORTED THAT AN OPEN REPAIR WAS TO BE SCHEDULED; HOWEVER ON (B) (6) 2010, AN ADDITIONAL REPORT WAS RECEIVED THAT PATIENT DIED ONE WEEK AFTER POST-IMPLANT DUE TO A RUPTURED AAA.

    Description of Event or Problem · 1

    INITIAL REPORT: PATIENT PRESENTED WITH CALCIUM IN THE ILIACS THAT WAS NOT FULLY APPRECIATED ON CT. VESSELS WERE DILATED WITH 6 AND 8MM BALLOONS. DUE TO CALCIFICATION, THE 28-16-120BL BIFURCATED DEVICE WOULD NOT TRACK THROUGH THE ILIAC VESSELS. THE PHYSICIAN DECIDED TO ATTEMPT A TUBE GRAFT, STARTING WITH A 28-28-75L PROXIMAL EXTENSION; HOWEVER DUE TO CALCIFICATION WOULD NOT TRACK AS WELL. THE PATIENT WAS NOT TREATED AT THAT TIME AND WILL BE SCHEDULED FOR AN OPEN REPAIR AT A LATER DATE. ADDITIONAL INFORMATION PER REP ON 6/10/10 - PATIENT DIED ONE WEEK LATER DUE TO RUPTURED ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-120BL W09-3752-014

    Patients

    Seq Age Sex Outcome Treatment
    1 Death