BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021044 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00758
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    April 21, 2006
    Report Date
    April 21, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    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 9616099-2008-00757, AND 9616099-2008-00759. 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 AN ANTERIOR WALL NON-Q WAVE MYOCARDIAL INFARCTION DURING A PERCUTANEOUS CORONARY INTERVENTION. FEMORAL ACCESS WAS CHOSEN FOR THE PROCEDURE AND THE PATIENT RECEIVED HEPARIN AND IIB/IIIA INHIBITOR INFUSION DURING THE PROCEDURE. TARGET VESSEL WAS THE LEFT ANTERIOR DESCENDING CORONARY ARTERY AND THE FIRST DIAGONAL BIFURCATION. THE MAIN BRANCH WAS VISUALLY APPRAISED AS 3.0 X 55 LONG, DE NOVO, ECCENTRIC, MODERATE TO HEAVY CALCIFICATION, GREATER THAN 90-DEGREE ANGULATION AND A 95% STENOSIS. THE SIDE BRANCH WAS DESCRIBED AS 2.5 X 5MM LONG, DE NOVO, MODERATE TO HEAVY CALCIFICATION, GREATER THAN 90-DEGREE ANGULATION AND 95% STENOSIS. A 3.0 X 23MM CYPHER STENT WAS IMPLANTED IN THE MAIN BRANCH AT 13 ATMS. THE VESSEL WAS PRE-DILATED AT 6 ATMS WITH A 3.0 X 20MM UNKNOWN BALLOON. POST DILATATION WAS NOT CONDUCTED; KISSING BALLOON WAS CONDUCTED AT 10 ATMS WITH AN UNKNOWN 3.0 X 20MM BALLOON FOR RESIDUAL STENOSIS OF ZERO AND A TIMI FLOW OF 3 AFTER THE PROCEDURE. FOR THE SIDE BRANCH, A 2.25 X 23MM CYPHER STENT WAS DEPLOYED AT 13 ATMS. PREDILATATION WAS CONDUCTED WITH A 2.5 X 20MM UNKNOWN BALLOON AT 10 ATMS AND POST DILATATION WAS CONDUCTED WITH A 2.5 X 20MM UNKNOWN BALLOON AT 15 ATMS. KISSING BALLOON WAS ALSO CONDUCTED AT 15 ATMS WITH A 2.5 X 20MM UNKNOWN BALLOON FOR A RESIDUAL STENOSIS OF 40% AND A TIMI FLOW OF 3. A TRANSIENT VESSEL OCCLUSION OCCURRED AND IT WAS TREATED BY IMPLANTATION OF ANOTHER 2.75 X 18MM CYPHER STENT. ADDITIONALLY, AN ANTERIOR WALL NON Q-WAVE MYOCARDIAL INFARCTION OCCURRED DURING THE PROCEDURE.

    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 I0405159

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention UNKNOWN 3.0 X 20MM BALLOON| IIB/IIIA INHIBITOR| HEPARIN| UNKNOWN 2.5 X 20 BALLOON