BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1023350 · Received April 1, 2008

    Report

    Report Number
    9616099-2008-00830
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    February 19, 2008
    Report Date
    March 10, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POST DILATATION WAS CONDUCTED AT 16 ATMS AND A TIMI FLOW OF THREE WAS MAINTAINED. FOR THE DISTAL RIGHT CORONARY ARTERY, THREE CYPHER STENTS WERE IMPLANTED; A 3.5 X 28MM DEPLOYED AT 16 ATMS AND POST DILATED AT 16 ATMS, A 3.5 X 33MM DEPLOYED AT 16 ATMS AND POST DILATED AT 14 ATMS AND FINALLY A 3.5 13MM DEPLOYED AT 16 ATMS AND POST DILATED AT 14 ATMS. FINAL TIMI FLOW WAS 2. ALL THREE STENTS IN THE DISTAL RIGHT CORONARY ARTERY WERE POST DILATED FOR INSUFFICIENT FLOW. THE MYOCARDIAL INFARCTION REPORTED WAS ACCOMPANIED BY AN INCREASE IN CARDIAC ENZYMES. THE PT WAS DISCHARGED 5 DAYS LATER. THE PT ALSO RECEIVED A TEMPORARY PACE MAKER DURING THIS PROCEDURE. THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE US. HOWEVER, IT IS SIMILAR TO THE US CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS IS ONE OF FIVE PRODUCTS INVOLVED IN THE SAME PT REPORTED UNDER MFG NUMBERS 9616099-2008-00828, 9616099-2008-00829, 9616099-2008-00830, 9616099-2008-00831 AND 9616099-2008-00832. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE CORDIS CLINICAL STUDY REGISTRY INDICATED THAT A PT HAD AN UNDETERMINED INFERIOR WALL Q-WAVE MYOCARDIAL INFARCTION POST PROCEDURE. THE MAIN INDICATION FOR THE PROCEDURE WAS ACUTE INFERIOR WALL NON-ST ELEVATION MYOCARDIAL INFARCTION WITHIN 24 TO 72 HRS WITH A KILLIP CLASS OF II FROM HOSP ADMISSION TO INDEX PROCEDURE AND RESTING ECG CHANGES. A 2.75 X 13MM CYPHER STENT WAS IMPLANTED AT 16 ATMS IN THE CIRCUMFLEX (SEGMENT 12) TO TREAT A LESION DESCRIBED AS 2.75 X 13MM LONG, DE NOVO, IRREGULAR WITH LITTLE OR NO CALCIFICATION, A TYPE B2 CLASSIFICATION AND 85% STENOSIS WITH A TIMI FLOW OF THREE. PRE DILATATION WAS CONDUCTED AT 12 ATMS; POST DILATATION WAS NOT CONDUCTED. A TIMI FLOW OF THREE WAS MAINTAINED. AFTER PRE DILATATION OF THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY AT 12 ATMS, A 3.0 13MM CYPHER WAS DEPLOYED AT 16 ATMS TO TREAT A LESION DESCRIBED AS 3.0 X 13MM LONG, DE NOVO, NOT OSTIAL, A TYPE B2 CLASSIFICATION WITH 90% STENOSIS AND A TIMI FLOW OF THREE.

    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 13324879

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization GP IIB/IIIA INHIBITOR| HEPARIN