BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021289 · Received March 25, 2008

    Report

    Report Number
    9616099-2008-00777
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    May 2, 2007
    Report Date
    March 5, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 TWO PRODUCTS INVOLVED IN THE SAME PT REPORTED UNDER MANUFACTURING NUMBERS 9616099-2008-00777 AND 9616099-2008-00778. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE CORDIS CLINICAL STUDY REGISTRY INDICATED THAT A PT HAS AN UNDETERMINED NON W-WAVE MYOCARDIAL INFARCTION AFTER RECEIVING TWO CYPHER STENTS. THE MAIN INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. A 3.0X33MM CYPHER WAS DEPLOYED AT 16 ATMS IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) DESCRIBED AS 3.0X30MM LONG, DE NOVO, CONCENTRIC WITH MODERATE CALCIFICATION, A TYPE B2 CLASSIFICATION AND 990% STENOSIS. DEBULKING WITH A ROTABLATOR CONDUCTED AND THE VESSEL WAS PREDILATED AT 12 ATMS WITH AN UNK 2.5X15MM BALLOON. POST DILATATION WAS CONDUCTED AT 20 ATMS WITH AN UNK 3.25X15MM BALLOON. A SECOND 3.0X18MM CYPHER STENT WAS DEPLOYED IN THE PROXIMAL LAD AT 20 ATMS OVERLAPPING THE FIRST CYPHER STENT. THE VESSEL WAS 3.0X15MM LONG, DE NOVO, OSTIAL, IRREGULAR, MODERATELY CALCIFIED WITH A TYPE B2 CLASSIFICATION AND 90% STENOSIS. IT WAS ALSO REQUIRED DEBULKING WITH A ROTABLATOR AND WAS PREDILATED AT 14 ATMS WITH AN UNK 2.5X15MM BALLOON. POST DILATATION WAS CONDUCTED AT 20 ATMS WITH AN UNK 3.0X15MM BALLOON. FULL APPOSITION OF THE STENT WAS CONFIRMED BY INTRAVASCULAR ULTRASOUND, AND IT WAS REPORTED THAT THE STENT IMPLANTED IN THE OSTIAL LAD EXTENDED INTO THE ENTIRE LEFT MAIN. A PROCEDURAL COMPLICATION OF HEMOGLOBIN DROP/HEMODILUTION DUE TO BLOOD LOSS FROM THE 7FR GUIDING CATHETER DURING THE FOUR HOURS AND FORTY-FIVE MINUTE PROCEDURE WAS REPORTED. THERE WAS NO ACTIVE BLEEDING AT THE SITE. THE NEXT DAY AFTER THE PROCEDURE, AN UNDETERMINED NON W-WAVE MYOCARDIAL INFARCTION WAS DIAGNOSED BASED ON ELEVATION OF CARDIAC ENZYMES. THERE WAS NO ISCHEMIC CHEST PAIN OR ECG CHANGES. THE PT WAS DISCHARGED HOME TWO DAYS LATER ON ASPIRIN, CLOPIDOGREL, STATINS AND BETA-BLOCKERS.

    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 13190816

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization INTEGRELLIN| HEPARIN| CLOPIDOGREL| ASPIRIN