BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1471996 · Received September 11, 2009

    Report

    Report Number
    2031527-2009-00107
    Event Type
    Death
    Date Received
    September 11, 2009
    Date of Event
    August 11, 2009
    Report Date
    September 10, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FOR PROXIMAL EXTENSION: MODEL NO. 34-34-80LE, LOT NO. W09-1920-009, EXPIRATION DATE: 8/1/12. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. THIS EVENT IS OFF-LABEL DUE TO THE PATIENT PRESENTING WITH A RUPTURE. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE ER VIA HELICOPTER WITH A FULL ANEURYSM RUPTURE. THE VISCERAL VESSELS WERE CONTINUALLY BLEEDING. THE PHYSICIAN WAS ABLE TO IMPLANT A 28-16-120B; BIFURCATED DEVICE AND A 34-34-80LE INFRARENAL PROXIMAL EXTENSION WITH GOOD SEAL IN AORTA. HOWEVER, THE PATIENT CONTINUED TO HEMORRHAGE OTHER VESSELS AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-120BL W09-1848-003

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R