BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 712508 · Received May 8, 2006

    Report

    Report Number
    3003742446-2006-00315
    Event Type
    Injury
    Date Received
    May 8, 2006
    Date of Event
    April 6, 2006
    Report Date
    May 8, 2006
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PCI WAS PERFORMED ON DE NOVO BIFURCATION LESION IN THE OBTUSE MARGINAL AND THE CIRCUMFLEX OF 20MM IN LENGTH IN A 2.5MM VESSEL DIAMETER BY SIMULTANEOUS KISSING TECHNIQUE. AFTER THE FIRST STENT WAS DEPLOYED, ANGIOGRAPHICALLY, IT APPEARED TO HAVE SHORTENED OR ACCORDIANED. A SECOND STENT WAS DEPLOYED TO TREAT THE LESION. THE REPORTER IS UNCLEAR WHICH OF THE TWO STENTS IS INVOLVED. THERE WAS NO INJURY TO THE PT. THE STENT DELIVERY SYSTEMS ARE BEING RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS LLC (PR) NA X0206711

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R