BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1210623 · Received October 23, 2008

    Report

    Report Number
    3003742446-2008-00227
    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

    REPORT WAS RECEIVED REGARDING POTENTIAL LEGAL ACTION INVOLVING A PRESUMED STENT THROMBOSIS. REVIEW OF THE AVAILABLE INFO DOES NOT REVEAL SUFFICIENT INFO TO RELATE THE PROCEDURAL, PT OR TARGET LESION DETAILS. AN UNK CYPHER STENT WAS PLACED IN AN UNK CORONARY ARTERY OF A FEMALE PT AND SUBSEQUENTLY, THE PT SUFFERED A PRESUMED STENT THROMBOSIS. THE STENT IS UNAVAILABLE FOR ANALYSIS AND NO STERILE LOT NUMBER WAS PROVIDED. THE PRODUCT WAS NOT RETURNED FOR EVAL AND TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. STENT THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENT IMPLANTATION AND IS LISTED IN THE PRODUCT IFU (INSTRUCTIONS FOR USE) AS SUCH. REVIEW OF THE SEVERELY LIMITED INFO DOES NOT SUGGEST WHAT FACTORS MAY HAVE CONTRIBUTED TO THE PRESUMED STENT THROMBOSIS.

    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 ATTACHED FILE, THIS PT SUFFERED SERIOUS AND PERMANENT INJURY. IT IS PRESUMED THAT 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 Hospitalization| L