BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1212648 · Received October 24, 2008

    Report

    Report Number
    3003742446-2008-00234
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    September 30, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE PRODUCT/S REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM A POTENTIAL LEGAL/LITIGATION CASE INDICATED THAT A PATIENT SUFFERED SERIOUS AND PERMANENT INJURY. IT IS PRESUMED THAT THE PATIENT SUFFERED STENT THROMBOSIS. THERE IS NO OTHER INFORMATION AVAILABLE AT THIS TIME.

    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 Life Threatening