BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1676760 · Received May 7, 2010

    Report

    Report Number
    2031527-2010-00058
    Event Type
    Death
    Date Received
    May 7, 2010
    Date of Event
    April 19, 2010
    Report Date
    April 28, 2010
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNKNOWN AT THIS TIME; INFORMATION WAS REQUESTED FROM THE REPORTER. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. (B) (4) PATIENT HAD PRE-EXISTING SMA DISEASE; PHYSICIAN BELIEVES DEATH WAS DUE TO EMBOLIC EVENT LEADING TO AFIB-HYPOTENSION UNRELATED TO THE DEVICE.

    Description of Event or Problem · 1

    PATIENT HAD PRE-EXISTING, EXTENSIVE SMA DISEASE. ON 3/24/10, PATIENT IMPLANT OF A 28-16-120BL BIFURCATED DEVICE, A 34-34-80LE PROXIMAL EXTENSION AND A 16-16-55L LIMB EXTENSION. A FEW DAYS AFTER IMPLANT, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. NO ISSUES THAT WOULD HAVE CAUSED THE ABDOMINAL PAIN WERE FOUND BY THE PHYSICIAN SO THE PATIENT WAS SENT HOME. 6-7 DAYS LATER THE PATIENT RETURNED TO THE HOSPITAL AND WAS DIAGNOSED WITH BOWEL ISCHEMIA. THE PHYSICIAN WANTED TO SURGICALLY EXCISE THE NECROTIC AREA, BUT THE PATIENT DIED DURING THE PROCEDURE. EXACT DATE OF DEATH IS UNKNOWN AT THIS TIME. THE PHYSICIAN BELIEVES THE DEATH TO BE DUE TO AN EMBOLIC EVENT RESULTING IN AFIB-HYPOTENSION, UNRELATED 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 W10-0364-012

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R