BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 997369 · Received February 12, 2008

    Report

    Report Number
    9616099-2008-00310
    Event Type
    Death
    Date Received
    February 12, 2008
    Date of Event
    November 12, 2007
    Report Date
    January 18, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS IS ONE OF TWO PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MANUFACTURING REPORTS #: 9616099-2008-00310 AND 9616099-2008-00311. ANY ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT REC'D FROM THE REGISTRY INDICATES THAT PT EXPIRED APPROXIMATELY THREE MONTHS POST CYPHER STENT IMPLANT. IT IS UNKNOWN IF THE DEATH WAS CARDIAC OR NON-CARDIAC. AN AUTOPSY WAS NOT PERFORMED, HOWEVER, THE INITIAL REPORTER OF THE EVENT INDICATED THERE WAS NO EVIDENCE OF THROMBOSIS, OR MYOCARDIAL INFARCTION. THE PT WAS FOUND DEAD AT HOME, PROBABLY DUE TO AN UNBALANCED DIABETES COMA; THE PT HAS A MEDICAL HISTORY OF TYPE II DIABETES >20 YEARS CONTROLLED WITH INSULIN. THIS INFO WAS OBTAINED OVER THE PHONE WITH GENERAL PRACTITIONER. THE RELATIONSHIP TO THE CORDIS DEVICE AND INDEX PROCEDURE WAS DEEMED AS POSSIBLE. DURING THE FIRST MONTH FOLLOW-UP VISIT, THE PT WAS ASYMPTOMATIC, AND TAKING ALL OF HIS MEDICATIONS AS PLANNED AT DISCHARGE, AND ECHOCARDIOGRAM WAS PERFORMED WITH NORMAL RESULTS. IN ADDITION, FOLLOWING THE CLINICAL GUIDANCE PROVIDED, THIS EVENT WILL BE REPORTED FOR MDR AND A CODE FOR THROMBOTIC EVENT WILL BE ADDED TO THE FILE AS PER ACADEMIC RESEARCH CONSORTIUM(ARC) GUIDELINES.

    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 64 YR Death PILOT GUIDEWIRE