BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1230526 · Received November 12, 2008

    Report

    Report Number
    3003742446-2008-00258
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P20026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2008-00257 AND 3003742446-2008-00259.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAIN. ANGIOGRAPHY WAS DONE AND IT SHOWED STENT THROMBOSIS AS WELL AS STENT FRACTURES ON ALL THREE STENTS IMPLANTED IN THE RIGHT CORONARY ARTERY. THE PATIENT WAS TREATED WITH THE IMPLANT OF TAXUS STENTS.

    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