BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1080167 · Received July 21, 2008

    Report

    Report Number
    3003742446-2008-00131
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    January 1, 2006
    Report Date
    June 23, 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
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS REMAIN IMPLANTED IN THE PT AND ARE NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE MALE PT UNDERWENT CYPHER STENT IMPLANTATION TO AN UNKNOWN CORONARY VESSEL IN 2006. THE PT RECEIVED THREE CYPHER STENTS. IN 2007, HE WAS TAKEN OFF PLAVIX BUT CONTINUED TAKING ASPIRIN. IN 2008, THE PT HAD ANGINA. CATH REVEALED 85% BLOCKAGE IN TWO OF HIS STENTS ALONG WITH NEW LESIONS IN OTHER ARTERIES. HE IS SCHEDULED TO HAVE BYPASS SURGERY LATER THIS MONTH. NO FURTHER INFO AVAILABLE.

    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 84 YR Hospitalization| R ASPIRIN