BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1212533 · Received October 24, 2008

    Report

    Report Number
    3003742446-2008-00233
    Event Type
    Death
    Date Received
    October 24, 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 REPORT IS FOR AN UNKNOWN CYPHER STENT. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    JOHNSON & JOHNSON HAS BEEN INFORMED TO THE INTENT FOR LEGAL ACTION OR POTENTIAL LITIGATION, THERE IS NO OTHER INFORMATION AVAILABLE AT THIS TIME. BASED UPON THE ATTACHED FILE, THIS PATIENT DIED. IT IS PRESUMED THAT THE PATIENT SUFFERED STENT THROMBOSIS OF A CYPHER STENT.

    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 UNK Death