BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1612167 · Received February 23, 2010

    Report

    Report Number
    2031527-2010-00013
    Event Type
    Death
    Date Received
    February 23, 2010
    Date of Event
    January 21, 2010
    Report Date
    March 30, 2011
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. [(B) (4)] UNKNOWN IF PATIENT'S ANATOMY MET CRITERIA FOR INDICATIONS FOR USE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OBTAINED INDICATES PATIENT DIED (DATE UNKNOWN) OF A MYOCARDIAL INFARCTION UNRELATED TO THE USE OF THE POWERLINK SYSTEM.

    Description of Event or Problem · 1

    ON (B) (6) 2009, PATIENT IMPLANT OF A 25-16-140BL BIFURCATED DEVICE AND A 25-25-75L PROXIMAL EXTENSION WITH GOOD RESULTS. ONE MONTH FOLLOW UP APPEARED TO BE CLEAR WITH NO LEAKS, HOWEVER, AT A LATER FOLLOW UP (DATE UNKNOWN), IMAGES REVEALED THAT THE MAIN BODY CONNECTION TO THE BIFURCATED LIMBS AT THE DISTAL AORTA APPEARED TO BE COMPRESSED. ON (B) (6) 2010, THE PATIENT WAS TREATED WITH TWO 10X57 EXPRESS BARE METAL STENTS, USING THE "KISSING STENTS" TECHNIQUE AT THE BIFURCATION. THERE WAS GOOD FLOW AT THE CLOSE OF THE PROCEDURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-140BL W09-1849-002

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| R