BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040303 · Received May 7, 2008

    Report

    Report Number
    9616099-2008-01253
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 7, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITES STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PROD. THIS DEVICE IS ONE OF TWO PRODS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT #: 9616099-2007-02334. THE PROD REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE AVAILABLE IN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A MALE PT WAS ENROLLED IN THE STUDY IN 2007 WITH 1-VESSEL DISEASE. THE PT'S MEDICAL HISTORY INCLUDES PREVIOUS PERCUTANEOUS CORONARY INTERVENTION. THE MAIN INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE TARGET LESION WAS A NATIVE MID LEFT ANTERIOR DESCENDING IN WHICH A 3.0 X 8 MM CYPHER SELECT PLUS STENT AND ANOTHER UNK CYPHER SELECT WAS IMPLANTED. DURING THE PROCEDURE, THE PT EXPERIENCED CHEST PAIN AND HAND A NON Q-WAVE MYOCARDIAL INFARCTION IN AN UNDETERMINED LOCATION. THERE WAS NO EVIDENCE OF STENT THROMBOSIS. SLOW FLOW WAS NOTED AFTER STENT DEPLOYMENT. THE PT WAS DISCHARGED THE FOLLOWING DAY.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening ASPIRIN| CLOPIDOGREL