BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 604263 · Received May 19, 2005

    Report

    Report Number
    3003742446-2005-01425
    Event Type
    Injury
    Date Received
    May 19, 2005
    Date of Event
    January 27, 2005
    Report Date
    May 17, 2005
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE TREATING FACILITY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE TREATING FACILITY: THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CORONARY INTERVENTION DUE TO UNSTABLE ANGINA TWO LESIONS WERE TREATED WITH CYPHER STENTS AS FOLLOWS: MI CIRCUMFLEX ARTERY (MID CX) - CXS28250/A1204181. FIRST OBTUSE MARGINAL BRANCH (OMI) - CXS28250/A1204779. NO OTHER VESSEL/LESION CHARACTERISTICS ARE NOTED. FOLLOWING IMPLANTATION OF THE CYPHER IN THE OMI - A DISSECTION WAS NOTED DISTAL TO THE STENT. THIS WAS TREATED WITH BALLOON ANGIOPLASTY. MEDICATIONS ADMINISTERED DURING THE CASE INCLUDED HEPARIN AND INTEGRILLIN. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS LLC (PR) NA A1204779

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention