BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1181159 · Received September 30, 2008

    Report

    Report Number
    9616099-2008-02372
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    June 20, 2007
    Report Date
    September 2, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S HISTORY IS SIGNIFICANT FOR CORONARY ARTERY DISEASE, ORALLY TREATED DIABETES MELLITUS, AND SMOKER WAS ADMITTED FOR THE INDEX PROCEDURE WITH UNSTABLE ANGINA. PRIOR TO THE PROCEDURE, THE PATIENT WAS ON ASPIRIN, STATINS, AND CLOPIDOGREL. AT THE TIME OF THE PROCEDURE, THE PATIENT RECEIVED ASPIRIN, CLOPIDOGREL AND UNFRACTIONATED HEPARIN. THE ANGIOGRAM SHOWED TWO-VESSEL DISEASE, THE PROXIMAL/MID (LAD) LEFT ANTERIOR DESCENDING ARTERY AND THE DISTAL (RCA) RIGHT CORONARY ARTERY. THE LAD VESSEL DIAMETER WAS 2.75MM AND THE LESION LENGTH WAS 46MM. THE LESION WAS DESCRIBED AS DE NOVO, BIFURCATION REQUIRING DOUBLE GUIDEWIRE, IRREGULAR CONTOUR, MODERATE TORTUOSITY OF PROXIMAL SEGMENT, ANGULATIONS, ECCENTRIC, MODERATE CALCIFICATION, TYPE B2, AND 80% STENOSED. THE RCA VESSEL DIAMETER WAS 3.0MM AND THE LESION LENGTH WAS 10MM. THE LESION WAS DESCRIBED AS DE NOVO, SMOOTH CONTOUR, READILY ACCESSIBLY, CONCENTRIC, LITTLE CALCIFICATION, TYPE A, AND 99% STENOSED. A 6FRENCH-GUIDING CATHETER WAS UTILIZED TO CANNULATE BOTH VESSELS, AND TWO BMW GUIDEWIRES WERE UTILIZED TO CROSS THE LESION/BIFURCATION. THE LAD LESION WAS PRE-DILATED WITH 2X20MM UNKNOWN BRAND BALLOON AT 14 ATMOSPHERES. TWO CYPHER SELECT PLUS STENTS WERE DEPLOYED AT 14/18 ATMOSPHERES WITH SATISFACTORY RESULTS. THE STENT WAS POST-DILATED FOR OPTIMAL EXPANSION WITH A 2.75X28MM BALLOON AT 18 ATMOSPHERES. THE RCA LESION WAS CROSSING WITH BMW GUIDE WIRE, AND DIRECT STENTED WITH CYPHER SELECT PLUS STENT WAS DEPLOYED AT 14 ATMOSPHERES WITH SATISFACTORY RESULTS. AFTER THE PROCEDURE, THE PATIENT WAS PLACED ON ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS DISCHARGED HOME WITH CLOPIDOGREL FOR 12 MONTHS AND ASPIRIN PERMANENTLY, ORAL ANTIDIABETICS, STATINS, AND BETA-BLOCKERS. THIS PRODUCT IS SIMILAR TO US CYPHER. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT # 9616099-2008-02370 AND 9616099-2008-02371.

    Description of Event or Problem · 1

    PER THE STUDY DATABASE INDICATED THAT FOUR MONTHS POST PROCEDURE, THE PATIENT WAS SET UP FOR A STAGED PROCEDURE/RE-PCI-PERCUTANEOUS CORONARY INTERVENTION, DUE TO ANGIOGRAPHICALLY DRIVEN - SIGNIFICANT LESION JUDGED TO REQUIRE REVASCULARIZATION. THE TREATED SITE IS UNKNOWN. THE EVENT RESOLVED WITHOUT SEQUEL.

    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 I0806086

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R