BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001489 · Received February 19, 2008

    Report

    Report Number
    9616099-2008-00385
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 23, 2008
    Report Date
    January 25, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE TARGET LESION REFERENCE VESSEL DIAMETER WAS 2.5MM AND LESION LENGTH WAS 16MM. DIAMETER STENOSIS PRE-PROCEDURE WAS 99%. POST PROCEDURE WAS ZERO PERCENT. THE LESION WAS DENOVO, WITH NO MAJOR SIDE BRANCH INVOLVEMENT, IRREGULAR, WITH <45 DEGREE ANGULATION. THERE WAS LITTLE TO NO CALCIFICATION, CONCENTRIC AND WITHOUT THROMBUS. LESION CLASSIFICATION WAS TYPE A. A 6F GUIDING CATHETER WAS ALSO USED. THE LESION WAS PREDILATED WITH A 2.5X18MM BALLOON AT 8 ATMS. A 2.5X18MM CYPHER SELECT PULS STENT WAS DEPLOYED AT 14 ATMS. POST DILATATION WAS NOT PERFORMED. IVUS WAS NOT PERFORMED. THE PT WAS DISCHARGED ON ASPIRIN, ACE-INHIBITORS, STATINS, BETA-BLOCKERS, AND CLOPIDOGREL. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS PT WAS ENROLLED IN THE STUDY FOR ONE VESSEL DISEASE. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA PECTORIS. IT WAS REPORTED THAT DURING INJECTION OF 3CC OF CONTRAST MEDIA TO RIGHT CORONARY ARTERY (RCA), THIS PT DEVELOPED VENTRICULAR FIBRILLATION (VF). THE DC-SHOCK WAS DELIVERED, AND NORMAL SINUS RHYTHM (NSR) WAS RESTORED. THIS EVENT WAS REPORTED AS UNRELATED TO THE CORDIS DEVICE AND AS POSSIBLY RELATED TO THE INDEX PROCEDURE.

    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 13323045

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R 6F GUIDING CATHETER