BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1062870 · Received June 18, 2008

    Report

    Report Number
    3003742446-2008-00112
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    October 3, 2006
    Report Date
    May 22, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE FEMALE PT RECEIVED A 3.5X33MM CYPHER STENT IN THE PROXIMAL LAD IN 2005. IN 2006, THE PT HAD LATE THROMBOSIS IN THE IMPLANTED STENT.

    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 44 YR Hospitalization| R PLAVIX| ASPIRIN