BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1213822 · Received October 28, 2008

    Report

    Report Number
    9616099-2008-02555
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    October 13, 2006
    Report Date
    October 7, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE FEMALE PATIENT RECEIVED A 3.0 X 23MM CYPHER STENT IN THE DISTAL RCA AND A 2.5 X 18MM CYPHER STENT IN THE PROXIMAL LAD. AS IT WAS REPORTED BY THE ARTS STUDY: THE PATIENT WAS HOSPITALIZED EARLIER IN 2006, FOR A CORONARY ANGIOGRAPHY SHOWING ON SEGMENT 2ND DIAGONAL (90%STEN), RCA PROX (50%STEN), AND RCA MID (60% STENOSIS)(ALL TIMI FLOW 3). THE ANGIOGRAPHY WAS PERFORMED BASED ON ANGINAL COMPLAINTS. WITH THIS RESULT AND A DIAGNOSIS OF UNSTABLE ANGINA CLASS I B, THE SUBJECT WAS ADVISED TO COME BACK FOUR DAYS LATER, FOR A REVASCULARIZATION. DURING THE 2ND HOSPITALIZATION THE SUBJECT RECEIVED ELECTIVE PCI. THE 2ND DIAGONAL WAS REVASCULARIZED. DURING THIS PROCEDURE ONE GUIDING CATHETER, ONE GUIDE WIRE, ONE BALLOON AND A CYPHER STENT WITH DELIVERY SYSTEM. 90CC TOTAL AMOUNT OF CONTRAST USED. PROCEDURE WENT WITHOUT COMPLICATIONS AND SUBJECT WAS DISCHARGED THE FOLLOWING DAY.

    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 R0203092

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R