BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021045 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00757
    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
    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 9616099-2008-00757, 9616099-2008-00758 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 I0505121

    Patients

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