BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1190288 · Received October 6, 2008

    Report

    Report Number
    9616099-2008-02389
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    November 23, 2007
    Report Date
    September 12, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S HISTORY IS SIGNIFICANT FOR HYPERLIPIDEMIA, HYPERTENSION, PREVIOUS CORONARY BYPASS SURGERY (1992), MYOCARDIAL INFARCTION, AND MODERATE TO SEVERE RENAL DISEASE. THE PT WAS ON CLOPIDOGREL, ANTICOAGULANTS WITH AN INR OF 2, STATINS, AND ACE INHIBITORS. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA PECTORIS. INTRA-PROCEDURE MEDICATIONS CONSISTED OF A LOADING DOSE OF CLOPIDOGREL 600 MG, AND UNFRACTIONATED HEPARIN. THE ANGIOGRAM SHOWED TWO-VESSEL DISEASE, BUT ONLY THE MID (LAD) LEFT ANTERIOR DESCENDING ARTERY WAS TREATED. THE VESSEL DIAMETER WAS 2.5MM AND THE LESION LENGTH WAS 30MM. THE LESION WAS DESCRIBED AS DE NOVO, NON-OSTIAL, TYPE C, AND 95% STENOSED. A 6FRENCH-GUIDING CATHETER WAS UTILIZED TO CANNULATE THE VESSEL, AND THE LESION WAS DIRECT STENTED WITH THE DEPLOYMENT OF TWO CYPHER SELECT PLUS (2.5X13MM AND 2.5X23MM) STENTS AT 15 ATMOSPHERES. AFTER THE PROCEDURE, THE PT WAS PLACED ON ASPIRIN AND CLOPIDOGREL. THE PT WAS DISCHARGED HOME WITH CLOPIDOGREL, ANTICOAGULANTS WITH AN INR OF TWO, AND STATINS. THIS PRODUCT (CRB13250) IS SIMILAR TO US CYPHER. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS PRODUCT MALFUNCTION, WHICH IS ASSOCIATED WITH MFG REPORT # 9616099-2008-02390.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM STUDY FOR SUBJECT INDICATED THAT THIS PT WAS ADMITTED WITH UNSTABLE ANGINA APPROX THREE MOS AFTER THE INDEX PROCEDURE WITH UNSTABLE ANGINA, NO MARKER ELEVATION. THE ANGIOGRAPHY SHOWS A TOTAL OCCLUSION OF THE CYPHER STENTS PLACED IN THE MID (LAD) LEFT ANTERIOR DESCENDING ARTERY. A (PCI) PERCUTANEOUS CORONARY INTERVENTION WAS CONDUCTED WITH THE PLACEMENT OF A 3X12MM ENDEAVOR STENT. THE EVENT WAS HIGHLY PROBABLE TO THE DEVICE AND INDEX PROCEDURE. 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 13215798

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R