BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1212548 · Received October 27, 2008

    Report

    Report Number
    9616099-2008-02533
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 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
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OUS CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADDITIONAL INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING A YEARLY FOLLOW-UP, THE PT REPORTED EXPERIENCING ANGINA PECTORIS. THE PT WAS COMPLIANT WITH HIS MEDICATIONS. DURING AN UNSCHEDULED VISIT IN 2008 THE PT REPORTED EXPERIENCING ANGINA PECTORIS. THE PT WAS COMPLIANT WITH HIS MEDICATIONS. ANGIOGRAPHY WAS CONDUCTED AND 90% FOCAL RESTENOSIS WAS NOTED PROXIMAL, WITHIN 5MM, TO THE STENT THAT WAS ORIGINALLY IMPLANTED DURING THE INDEX PROCEDURE. THE RESTENOSIS WAS TREATED WITH A 2.25 X 24MM TAXUS STENT. A PT WAS INITIALLY ENROLLED IN THE STUDY IN 2007 WITH 3-VESSEL DISEASE. THE MAIN INDICATION FOR THE INTERVENTION WAS STABLE ANGINA PECTORIS. THE LESION TREATED WAS IN THE OTHER OBTUSE SEGMENTS. THE LESION HAD 90% STENOSIS AND WAS DE NOVO, SMOOTH AND ECCENTRIC. THE LESION WAS 12MM IN LENGTH AND THE VESSEL WAS 2.5MM IN DIAMETER. THE LESION WAS PRE-DILATED AND A 2.5 X 18MM CYPHER SELECT PLUS WAS ELECTIVELY IMPLANTED AT 16ATM. THE PT'S BASELINE MEDICATIONS INCLUDED ASPIRIN, ACE INHIBITORS, BETA-BLOCKERS AND OTHER LIPID LOWERING DRUGS. THE PT'S INTRA PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. THE PT'S POST PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL, ACE INHIBITORS AND OTHER LIPID LOWERING DRUGS.

    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 13226969

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R A 2.5 X 12MM BALLOON CATHETER| PROCEDURE: A 6F GUIDING CATHETER| THE FOLLOWING PRODUCTS WERE USED DURING THE| AND A WHISPER GUIDEWIRE.