BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 866629 · Received June 15, 2007

    Report

    Report Number
    9616099-2007-01127
    Event Type
    Injury
    Date Received
    June 15, 2007
    Date of Event
    May 17, 2007
    Report Date
    May 18, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A CODE FOR THROMBOSIS EVENT HAS BEEN ADDED TO THIS REPORT IN ACCORDANCE WITH THE ACADEMIC RESEARCH CONSORTIUM (ARC) GUIDELINES FOR THROMBOTIC EVENTS. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS IS ONE OF TWO PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MANUFACTURING REPORTS #: 9616099-2007-01127 AND 9616099-2007-01128. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE FOLLOWING REPORT WAS RECEIVED FROM THE CLINICAL STUDY: THE INDICATION FOR THE INDEX PROCEDURE WAS ACUTE MYOCARDIAL INFARCTION >72 HRS. TWO TYPE C LESIONS WERE TREATED AT INDEX PROCEDURE AT THE LEFT ANTERIOR DESCENDING ARTERY VIA DIRECT STENTING. FOLLOWING THE INDEX PROCEDURE, THE PATIENT DEVELOPED EXPRESSIVE/RECEPTIVE DYSPHASIA POST PCI AND SUBSEQUENT EMBOLIC STROKE OF THE LEFT MIDDLE CEREBRAL ARTERY. THIS EVENT WAS TREATED WITH ANTICOAGULANTS; WARFARIN THERAPY WAS COMMENCED. FIVE DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED ANGINA PECTORIS CONSISTENT WITH ISCHEMIC CHANGES ON ECG. AN ANGIOGRAM WAS PERFORMED REVEALING PATIENT STENTS, NO THROMBUS, NO NEW OBSTRUCTIVE DISEASE AND NO DISSECTIONS. THE CHEST PAIN WAS TREATED MEDICALLY WITH BETA-BLOCKER THERAPY. FIVE DAYS LATER, THE PATIENT EXPERIENCED A Q-WAVE MYOCARDIAL INFARCTION. THE EVENT WAS RESOLVED FIVE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ CORDIS DE MEXICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R