BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1210615 · Received October 23, 2008

    Report

    Report Number
    3003742446-2008-00222
    Event Type
    Injury
    Date Received
    October 23, 2008
    Report Date
    September 30, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PT SUFFERED A SERIOUS INJURY POST IMPLANTATION OF A CYPHER STENT. THIS INFO WAS PROVIDED IN A LEGAL FILE; NO DETAILS WERE AVAILABLE. IT IS PRESUMED THAT HE EXPERIENCED STENT THROMBOSIS. NO PRODUCT WAS RETURNED FOR EVAL. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. STENT THROMBOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE LIMITED INFO AVAILABLE DOES NOT MAKE IT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    JOHNSON & JOHNSON HAS BEEN INFORMED OF THE INTENT FOR LEGAL ACTION OR POTENTIAL LITIGATION, THERE IS NO OTHER INFO AVAILABLE AT THIS TIME. BASED UPON THE INFO THAT WAS RECEIVED, THIS PT SUFFERED SERIOUS AND PERMANENT INJURY. IT IS PRESUMED AND THE PT SUFFERED STENT THROMBOSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening