BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1130915 · Received August 21, 2008

    Report

    Report Number
    9616099-2008-02049
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    December 18, 2007
    Report Date
    July 28, 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

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. THIS CYPHER 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

    THIS PT WAS ENROLLED IN THE STUDY IN 2007 WITH 3-VESSEL DISEASE. THE MAIN INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA PECTORIS. DURING AN UNSCHEDULED VISIT SEVEN MONTHS POST INDEX PROCEDURE THE PT WAS EXPERIENCING ANGINA PECTORIS AND HAD A POSITIVE STRESS TEST. ANGIOGRAPHY WAS PERFORMED WHICH REVEALED A LATE STENT THROMBOSIS. THIS WAS TREATED WITH THE IMPLANT OF A TAXUS LIBERTE STENT. THE EVENT WAS RESOLVED WITHOUT SEQUEL. THE TARGET LESION WAS A NATIVE, DE NOVO, OSTIAL, SMOOTH, READILY ACCESSIBLE, ECCENTRIC, MODERATELY CALCIFIED, TYPE C PROXIMAL CIRCUMFLEX ARTERY WITH THROMBUS PRESENT. THE REFERENCE VESSEL DIAMETER WAS 2.5MM AND THE LESION LENGTH WAS 20MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 90%. THE LESION WAS PRE-DILATED WITH A 2.75X33MM BALLOON AT 14 ATM AND A 2.75X33MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 14ATM WITH SATISFACTORY RESULTS. THE STENT WAS POST-DILATED WITH A 2.75X33MM BALLOON AT 18ATM. POST-PROCEDURE DIAMETER STENOSIS WAS 0%. THE PT'S PRE-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, STATINS, AND BETA-BLOCKERS. THE PT'S INTRA-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, CLOPIDOGREL AND REOPRO. THE PT'S POST-PROCEDURE MEDICATIONS INCLUDED: ASPIRIN, STATINS, ACE INHIBITORS, BETA-BLOCKERS AND CLOPIDOGREL.

    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 I1106024

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R 6F GUIDING CATHETER| BMW WIRE| 2.75X33MM BALLOON