BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1201541 · Received October 17, 2008

    Report

    Report Number
    3003742446-2008-00204
    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

    THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONALLY, THE STERILE LOT NUMBER IS NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED BASED ON THE AVAILABLE INFO, IT IS NOT POSSIBLE TO DRAW A CONCLUSION REGARDING THE REPORTED EVENT. IT IS ALSO NOT POSSIBLE TO DETERMINE WHAT, IF ANY, CLINICAL FACTORS MAY HAVE CONTRIBUTED.

    Description of Event or Problem · 1

    CORDIS HAS BEEN NOTIFIED THROUGH LEGAL CHANNELS THAT A MALE PATIENT UNDERWENT IMPLANTATION OF AN UNKNOWN NUMBER OF UNIDENTIFIED CYPHER STENTS IN A CORONARY UNKNOWN ARTERY/ ARTERIES. SOMETIME AFTER IMPLANTATION, THE PATIENT EXPERIENCED IN-STENT THROMBOSIS. NO FURTHER INFO REGARDING THE PATIENT, PRODUCT, PROCEDURE, OR EVENT IS 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