BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 703458 · Received April 19, 2006

    Report

    Report Number
    9616099-2006-00440
    Event Type
    Injury
    Date Received
    April 19, 2006
    Date of Event
    December 14, 2005
    Report Date
    April 19, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEVEN DAYS FOLLOWING THE INDEX PROCEDURE THE PATIENT COMPLAINED OF CHEST PAIN AND CAME TO THE HOSPITAL. DECREASE IN ST WAS CONFIRME. CAG WAS CONDUCTED AND THROMBUS WAS OBSERVED IN THE CYPHER STENT. TO TREAT THE THROMHUS, ASPIRATION AND POBA WAS CONDUCTED. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. THREE MONTH LATER A FOLLOW-UP CAG WAS CONDUCTED AND THE CYHPHER DES WAS PATENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| L| R