BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083531 · Received July 23, 2008

    Report

    Report Number
    9616099-2008-01834
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    August 17, 2006
    Report Date
    June 27, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE STUDY. THE PT HAD A TWO CRA18300 STENTS PLACED IN THE BIFURCATION OF THE LEFT ANTERIOR DESCENDING AND THE 1ST DIAGONAL IN 2006. DURING THE PROCEDURE, A TYPE A DISSECTION OF THE MAIN BRANCH (PROXIMAL LEFT ANTERIOR DESCENDING) OCCURRED AND AN ADD'L STENT 3.0 X 18 CYPHER STENT WAS IMPLANTED, OVERLAPPING THE FIRST. THERE WERE NO ECG CHANGES OR CARDIAC ENZYME INCREASE FOLLOWING THE DISSECTION. THE INDICATION FOR THE INDEX PROCEDURE IS UNKNOWN. THE TARGET LESION WAS A SAFIAN BIFURCATION. AT THE MAIN BRANCH, PREDILATATION WAS PERFORMED USING A 3.0X15MM BALLOON AT 8 ATMS, FOLLOWED BY DEPLOYMENT OF THE FIRST 3.0X18MM CYPHER STENT AT 8 ATMS. POST DILATATION WAS PERFORMED (KISSING BALLOON) USING A 3.0X18MM BALLOON AT 14 ATMS. FINAL TIMI FLOW WAS III AND FINAL STENOSIS WAS 10%. AT THE SIDE BRANCH THE LESION WAS ECCENTRIC DIFFUSE, AND OSTIAL. PREDILATION WAS PERFORMED USING A 2.5X15MM BALLOON AT 10 ATMS. POST-DILATATION WAS DONE USING A 2.5 X 15 MM BALLOON AT 6 ATMS (KISSING BALLOON PERFORMED) AT 10 ATMS. FINAL TIMI FLOW WAS III AND FINAL STENOSIS WAS 10%.

    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 I0606062

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 3.0X15MM BALLOON| 3.0X18MM BALLOON| (2) 2.5X15MM BALLOON