BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001508 · Received February 20, 2008

    Report

    Report Number
    9616099-2008-00413
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    October 6, 2007
    Report Date
    January 29, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MANUFACTURING REPORTS #: 9616099-2008-00412 AND 9616099-2008-00413. IN ADDITION A PREVIOUS ADVERSE EVENT INVOLVING THESE SAME DEVICES WAS REPORTED UNDER MANUFACTURING REPORT NUMBER 9610978-2004-00307. PLEASE NOTE: DEVICE (LOT # R1203423) IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE TYPHOON CLINICAL STUDY INDICATES THAT THE PATIENT WAS HOSPITALIZED FOR A MYOCARDIAL INFARCTION AND PERCUTANEOUS CORONARY INTERVENTION. THE INITIAL REPORTER OF THIS EVENT HAS INDICATED THAT THERE IS NO ADDITIONAL INFORMATION AVAILABLE FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA R1203423

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| L| R