BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER 635 SELF-EXPANDING VASCULAR STENT

    MDR report key: 1231587 · Received November 14, 2008

    Report

    Report Number
    1820334-2008-00631
    Event Type
    Injury
    Date Received
    November 14, 2008
    Report Date
    October 16, 2008
    Manufacturer
    COOK, INC.
    Product Code
    NIO
    PMA / PMN Number
    P050017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATION: THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THREE DEVICES WERE PLACED AT THREE DIFFERENT TIMES. DEVICES WERE PLACED IN DIALYSIS GRAFT FISTULA DUE TO AN ANEURYSM ABOVE AND STENOSIS BELOW. THE ANEURYSM WAS IN THE NATIVE VESSEL AND THE STENOSIS WAS IN THE FISTULA. DURING PATIENT FOLLOW-UP IN EARLY OCTOBER, STENT FRACTURES WERE NOTED. IT WAS REPORTED THAT THE PATIENT EXPIRED AT A LATER DATE DUE TO UNKNOWN CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZILVER 635 SELF-EXPANDING VASCULAR STENT NIO VASCULAR STENT NIO COOK, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| O