BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1458410 · Received August 27, 2009

    Report

    Report Number
    2031527-2009-00103
    Event Type
    Death
    Date Received
    August 27, 2009
    Date of Event
    July 24, 2009
    Report Date
    August 24, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION FOR ADDITIONAL LIMB EXTENSIONS: DEVICE 2) MODEL NO. 20-20-55L, LOT NO. W09-0384-014, EXPIRATION DATE: 3/1/12. DEVICE 3) MODEL NO. 16-16-88L, LOT NO. W09-0205-021, EXPIRATION DATE: 3/1/12. DEVICE 4) MODEL NO. 16-16-88L, LOT NO. W09-0205-022, EXPIRATION DATE: 3/1/12. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR TO REPORTS. NO ISSUES WERE NOTED. PATIENT HAD HISTORY OF HYPERTENSION AND STROKE. USE OF PALMAZ STENT IS OFF-LABEL. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT HAD BEEN DIAGNOSED WITH 7.5MM HEPATIC ARTERY ANEURYSM AND A POPLITEAL ANEURYSM. PATIENT ALSO HAD BILATERAL ILIAC ANEURYSMS. A 16-16-88L LIMB EXTENSION AND 20-20-55L LIMB EXTENSION WERE PLACED IN THE RIGHT ILIAC. ANOTHER 16-16-88L LIMB EXTENSION AND 20-20-55L LIMB EXTENSION WERE PLACED IN THE LEFT ILIAC. A PALMAZ STENT WAS ALSO PLACED ON THE LEFT SIDE. BOTH SIDES HAD GOOD RESULTS. THE NEXT DAY WHILE IN RECOVERY, THE PATIENT HAD A HEART ATTACK AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM LIMB EXTENSION STENT GRAFT MIH ENDOLOGIX, INC. 20-20-55L W09-0384-007

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R