BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 667801 · Received December 20, 2005

    Report

    Report Number
    9616099-2005-01704
    Event Type
    Injury
    Date Received
    December 20, 2005
    Date of Event
    October 30, 2005
    Report Date
    December 20, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SIX DAYS POST INDEX PROCEDURE THE PT COMPLAINED OF CHEST PAIN WHILE IN THE HOSP. CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE IMPLANTED CYPHER STENT AT THE LEFT MAIN. TO TREAT THE THROMBUS, POBA WAS CONDUCTED WITH A 1.5X UNK MM BALLOON. THEN POBA WAS CONDUCTED WITH TWO 3.25X UNK MM BALLOONS BY KBT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT CYPHER STENT NIQ CORDIS DE MEXICO NA 10705082

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R