BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1201538 · Received October 17, 2008

    Report

    Report Number
    3003742446-2008-00200
    Event Type
    Injury
    Date Received
    October 17, 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, PATIENT OR TARGET LESION DETAILS. AN UNK CYPHER STENT WAS PLACED IN AN UNK CORONARY ARTERY OF A MALE PATIENT AND SUBSEQUENTLY, THE PATIENT SUFFERED A PRESUMED STENT THROMBOSIS. THE STENT IS UNAVAILABLE FOR ANALYSIS AND NO STERILE LOT NUMBER WAS PROVIDE. THE PRODUCT WAS RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW WOULD NOT BE PERFORMED. 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 INFORMATION AVAILABLE AT THIS TIME. BASED UPON THE ATTACHED FILE, THIS PATIENT SUFFERED SERIOUS AND PERMANENT INJURY. IT IS PRESUMED THAT THE PATIENT 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 UNK Hospitalization| L