BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1449388 · Received August 19, 2009

    Report

    Report Number
    2031527-2009-00095
    Event Type
    Injury
    Date Received
    August 19, 2009
    Date of Event
    July 1, 2009
    Report Date
    August 17, 2009
    Manufacturer
    ENDOLOGIX INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO FOR BIFURCATED DEVICE: MODEL NO. 28-16-140BL, LOT NO. W09-1197-001, EXPIRATION DATE: 05/01/2012. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. UNK IF PT MET ALL INDICATIONS FOR USE CRITERIA. NO CONCLUSION AS TO THE CAUSE OF THE PERSISTENT ENDOLEAK CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PT PRESENTED WITH 3CM SEAL ZONE WITH 32-30-32MM (HOURGLASS) DIAMETER. IN 2009, ACCESS AND DEPLOYMENT OF A 28-16-140BL BIFURCATED DEVICE AND A 34-34-80LE INFRARENAL PROXIMAL EXTENSION WERE UNEVENTFUL. THERE WAS A SLIGHT INTRAOPERATIVE PROXIMAL TYPE I ENDOLEAK, WHICH COULD NOT BE RESOLVED WITH BALLOON POST DILATATION. A PALMAZ STENT WAS PLACED WITH GOOD SEAL. AT 30 DAY FOLLOW-UP, CT REVEALED BOTH A PROXIMAL AND DISTAL TYPE I ENDOLEAK. THE FOLLOWING MONTH, THE PT WAS TREATED FOR BOTH LEAKS. THE HYPOGASTRICS WERE COILED OFF AND A 16-16-88L LIMB EXTENSION WAS PLACED TO EXTEND DOWN THE RIGHT SIDE, WITH GOOD SEAL. A LARGE NON-COMPLIANT BALLOON WAS INFLATED IN THE PROXIMAL EXTENSION AND A PALMAZ STENT WAS PLACED, BUT THERE WAS STILL A SLIGHT LEAK. APPROX 20 COILS WERE PLACED AT THE NECK AND IN THE SAC, SOME COILS INADVERTENTLY ENDED UP BETWEEN THE GRAFT MATERIAL AND THE STENT CAGE. THE ENDOLEAK PERSISTED. A 34-34-80LE INFRARENAL PROXIMAL EXTENSION AND A 34-34-100RLE SUPRARENAL PROXIMAL EXTENSION WERE PLACED TO RELINE BOTH THE MAIN BODY AND ORIGINAL PROXIMAL EXTENSION. THE ENDOLEAK STILL PERSISTED. AT THIS POINT, THE CASE HAD LASTED APPROX 6-7 HOURS. THE LEAK WAS LEFT FOR MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION MIH ENDOLOGIX INC. 34-34-80LE W09-1262-009

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention