BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 642717 · Received October 20, 2005

    Report

    Report Number
    9616099-2005-01542
    Event Type
    Injury
    Date Received
    October 20, 2005
    Date of Event
    June 26, 2005
    Report Date
    October 19, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD A VASOSPAM THAT WAS TREATED WITH NITRATES. THIS PATIENT PRESENTED TO CATH WITH BP 140/90, 50% LVEF, INFERIOR MI AND 1-VESSEL DISEASE WAS FOUND. PRE-PROCEDURE CK-MB WAS FOUR TIMES ABOVE THE UPPER NORMAL LIMITS. ASA WAS THE PRE-PROCEDURE MEDICATION. INTRA-PROCEDURE MEDICATIONS INCLUDED PLAVIX, HEPARIN, AND OTHER GP LLB/LLLA INHIBITORS (INTEGRILLIN). THIS PATIENT WAS RANDOMIZED TO THE CYPHER ARM OF THE STUDY. PCI WAS PERFORMED ON A DE NOVO LESION IN THE DISTAL CIRCUMFLEX OF 12MM IN LENGTH IN A 3.0MM DIAMETER VESSEL WITH MODERATE TORTUOSITY OF THE PROXIMAL SEGMENT AND AT A BIFURCATION WITH NO MAJOR SIDE BRANCH INVOLVEMENT. THE (B2) ECCENTRIC LESION WAS CHARACTERIZED AS TOTALLY OCCLUDED, IRREGULAR CONTOUR, ANGULATION BETWEEN 45 AND 90 DEGREES, LITTLE TO NO CALCIFICATION AND THROMBUS PRESENT. DIRECT STENTING WAS PERFORMED WITH A 3.0X18MM CYPHER (LOT # UNKNOWN) AT 12 ATM WITH SATISFYING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTNG STENT NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R