BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 930603 · Received October 22, 2007

    Report

    Report Number
    9616099-2007-02071
    Event Type
    Death
    Date Received
    October 22, 2007
    Date of Event
    September 16, 2007
    Report Date
    September 26, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: THIS OUS CYPHER SELECT SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    TWENTY-EIGHT DAYS POST INDEX PROCEDURE, THE COMPLAINT EXPERIENCED ANGINA PECTORIS. ONE HUNDRED AND SEVENTY FOUR DAYS POST INDEX PROCEDURE, IT WAS NOTED THAT THE PATIENT STOPPED TAKING HER PLAVIX AND THE EXPERIENCED ANGINA PECTORIS FIVE DAYS LATER. SHE WAS SENT BACK TO THE CATHETERIZATION LAB WHERE THROMBUS WAS NOTED IN THE CIRCUMFLEX. IMMEDIATELY AFTER THE CORONARY ANGIOGRAM THE PATIENT DIED ON THE TABLE (VENTRICULAR FIBRILLATION). IT WAS ALSO CONFIRMED THAT THE PATIENT EXPERIENCED A NON-Q WAVE MYOCARDIAL INFARCTION. THE PATIENT WAS ADMITTED WITH UNSTABLE ANGINA PECTORIS IN 2007. THE PATIENT HAD 80% AND 70% DE NOVO LESIONS IN THE PROXIMAL LEFT ANTERIOR DESCENDING BRANCH AND IN THE PROXIMAL CIRCUMFLEX, RESPECTIVELY. THE LESIONS WERE TYPE A, BIFURCATED, OSTIAL, SMOOTH AND ECCENTRIC. THE LESIONS WERE 10MM IN LENGTH AND THE VESSELS WERE 25MM IN DIAMETER. A 2.5X 18MM CYPHER SELECT PLUS STENT WAS IMPLANTED AT 12ATM TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING BRANCH AND A 2.5 X 18MM CYPHER SELECT STENT WAS IMPLANTED AT 12ATM TO TREAT THE PROXIMAL CIRCUMFLEX. THE STENTS WERE IMPLANTED OVERLAPPING EACH OTHER. THE PATIENT'S MEDICATIONS INCLUDE THE FOLLOWING: ASPIRIN (PRE, INTRA AND POST PROCEDURE), STATINS (PRE AND POST PROCEDURE), ACE INHIBITORS (PRE AND POST PROCEDURE), BETA-BLOCKERS (PRE AND POST PROCEDURE), CLOPIDOGREL (INTRA ND POST PROCEDURE) AND HEPARIN (INTRA 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 I0906088

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death 8F GUIDING CATHETER| 2.5 XMM BALLOON