BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1221983 · Received November 3, 2008

    Report

    Report Number
    9616099-2008-02594
    Event Type
    Injury
    Date Received
    November 3, 2008
    Date of Event
    December 20, 2007
    Report Date
    October 3, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THREE MONTH POST INDEX PROCEDURE, THE PT HAD EVIDENCE OF MYOCARDIAL INFARCTION (MI), WHICH WAS LATERAL WITH Q-WAVE AND WAS THROMBOSED WITH STREPTOKINASE AT ANOTHER CENTER. THE PT HAD CORONARY ANGIOGRAPHY, WHICH REVEALED PT LAD STENT WITH OSTIAL STENOSIS OF LARGE DIAGONAL 1 AND LCX. PATIENT ALSO HAD CALCIFIED AORTIC STENOSIS MODERATE WITH AVA=1.06CM. THE PT UNDERWENT AORTIC VALVE REPLACEMENT AND CORONARY ARTERY BYPASSES (CABG) TO DIAGONAL ONE AND OBTUSE MARGINAL BRANCHES. PERI-STENT RESTENOSIS PATTERN (5 MM) NONE. INDEX PROCEDURE: THIS MALE PT WITH SINGLE VESSEL DISEASE MID LEFT ANTERIOR DESCENTING ARTERY (LAD) , WITH HISTORY OF HYPERTENSION, STABLE ANGINA PECTORIS, MYOCARDIAL INFARCTION (MI), 99% STENOSIS, DE NOVO, SMOOTH, CONCENTRIC, TYPE "C". THE LESION WAS PRE-DILATED USING A 2X20 BALLOON AT 10 ATM. A CYPHER SELECT PLUS STENT WAS DEPLOYED AT 16 ATM WITH INSUFFICIENT FLOW. THE STENT WAS POST DILATED USING A 18 X 3 BALLOON AT 12 ATM. THE PT WAS DISCHARGED TWO DAYS LATER.

    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 13202333

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR