BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SELECT 2.50 X 18MM

    MDR report key: 561642 · Received December 22, 2004

    Report

    Report Number
    9610978-2004-01185
    Event Type
    Death
    Date Received
    December 22, 2004
    Date of Event
    November 3, 2004
    Report Date
    December 22, 2004
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HYPERSENSITIVITY/SAT/DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SELECT 2.50 X 18MM DRUG-ELUTING STENT NIQ CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death| H| L| R 2.5 X 20 MAVERICK BALLOON.