BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021051 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00764
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    October 22, 2004
    Report Date
    May 16, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS IS ONE OF THREE PRODUCTS INVOLVED IN THE SAME PATIENT REPORTED UNDER MANUFACTURING NUMBERS 9616099-2008-00762, 9616099-2008-00763 AND 9616099-2008-00764. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE CLINICAL STUDY REGISTRY INDICATED THAT A PATIENT HAD A POST PROCEDURAL NON Q-WAVE MYOCARDIAL INFARCTION RELATED TO TARGET VESSEL. FEMORAL ACCESS WAS CHOSEN FOR THE PROCEDURE AND THE PATIENT RECEIVED ASPIRIN, HEPARIN AND IIB/IIIA INHIBITOR INFUSION DURING THE PROCEDURE. TARGET VESSEL WAS THE PROXIMAL CIRCUMFLEX AND THE OBTUSE MARGINAL BIFURCATION CLASSIFIED AD TYPE A. THE MAIN BRANCH WAS VISUALLY APPRAISED AS 2.5 X 12MM LONG, DE NOVO, ECCENTRIC, LITTLE OR NO CALCIFICATION, ECCENTRIC AND OSTIAL WITH A LESS THAN 45-DEGREE ANGULATION AND 90% STENOSIS. TIMI FLOW WAS THREE PRIOR TO THE PROCEDURE. THE SIDE BRANCH WAS DESCRIBED AS 2.25 X 12MM LONG, DE NOVO, LITTLE OR NO CALCIFICATION, ECCENTRIC, LESS THAN 45-DEGREE ANGULATION AND 90% STENOSIS. A 2.5 X 23MM CYPHER STENT WAS IMPLANTED IN THE MAIN BRANCH AT 18ATMS. THE VESSEL WAS PRE DILATED AT 10 ATMS WITH A 2.5 X 20MM UNKNOWN BALLOON. AN ADDITIONAL 2.5 X 13MM CYPHER WAS DEPLOYED AT 18 ATMS. POST DILATION WAS NOT CONDUCTED; KISSING BALLOON WAS CONDUCTED AT 8 ATMS WITH AN UNKNOWN 3.0 X 20MM BALLOON FOR A RESIDUAL STENOSIS OF ZERO AND A TIMI FLOW OF 3 AFTER THE PROCEDURE. FOR THE SIDE BRANCH, A 2.25 X 13MM CYPHER STENT WAS DEPLOYED AT 17 ATMS. PREDILATATION AND WAS CONDUCTED WITH A 2.0 X 20MM UNKNOWN BALLOON AT 10 ATMS AND POST DILATATION WAS NOT CONDUCTED. KISSING BALLOON WAS ALSO CONDUCTED AT 12 ATMS WITH A 2.0 X 15MM UNKNOWN BALLOON FOR A RESIDUAL STENOSIS OF ZERO AND A TIMI FLOW OF 3. A POST PROCEDURAL NON Q-WAVE MYOCARDIAL INFARCTION RELATED TO THE TARGET VESSEL WAS REPORTED AND CARDIAC ENZYMES WERE ELEVATED. THERE WAS NO ECG CHANGES AND THERE WAS NO TREATMENT.

    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 I0905087

    Patients

    Seq Age Sex Outcome Treatment
    1 IIB/IIIA INHIBITORS| ASPIRIN| HEPARIN