BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1212537 · Received October 27, 2008

    Report

    Report Number
    3003742446-2008-00245
    Event Type
    Injury
    Date Received
    October 27, 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

    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. THE PRODUCT/S REMAIN IMPLANTED IN THE PT AND ARE THUS NOT AVAILABLE FOR EVAL. A REVIEW OF THE MFG RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. BASED ON THE LIMITED INFO PROVIDED AND WITHOUT THE PRODUCT/S AVAILABLE FOR ANALYSIS, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE/S AND THE EVENT. PLEASE NOTE THAT THIS IS THE INITIAL/FINAL REPORT FOR THIS PRODUCT.

    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 UNK Hospitalization| L| R