BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1698533 · Received May 25, 2010

    Report

    Report Number
    2031527-2010-00068
    Event Type
    Death
    Date Received
    May 25, 2010
    Date of Event
    March 1, 2010
    Report Date
    May 19, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT IS UNKNOWN AT THIS TIME. INFORMATION HAS BEEN REQUESTED OF THE REPORTER. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES HAVE BEEN NOTED. PATIENT HAD ISCHEMIC BOWEL DISEASE WHICH CAUSED PATIENT DEATH.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH AAA, PERIPHERAL ARTERIAL DISEASE; LIFELONG SMOKER. ON (B) (6) 2010, PATIENT IMPLANT OF A 28-16-120BL BIFURCATED DEVICE, A 38-40MM TALENT STENT GRAFT, A UNILATERAL RENAL STENT. PATIENT WAS NEVER DISCHARGED FROM HOSPITAL; POST-PROCEDURE (DATE UNKNOWN), PATIENT COMPLAINED OF A COLD RIGHT LEG. PATIENT WAS CHECKED FOR PULSE ON THE RIGHT LEG AND DUE TO WEAK PULSE/BLOOD FLOW WAS SENT FOR A THROMBECTOMY WHERE A 3-5 CM CLOT WAS REMOVED. THE PATIENT DEVELOPED ISCHEMIC BOWEL DISEASE AND UNDERWENT REMOVAL OF NECROTIC GROIN TISSUE AND A COLON RESECTION. THE PATIENT DIED AFTER THIS PROCEDURE (LATE MARCH, EXACT DATE UNKNOWN). THE DEATH WAS CAUSED BY ISCHEMIC BOWEL; THE PHYSICIAN HAS CONCLUDED THAT THE PATIENT¿S DEATH IS NOT RELATED TO THE USE OF THE ENDOLOGIX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-120BL W09-3617-019

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H| R