BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1210619 · Received October 23, 2008

    Report

    Report Number
    3003742446-2008-00219
    Event Type
    Injury
    Date Received
    October 23, 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

    THIS MALE PT HAD ONE CYPHER STENT IMPLANTED IN HIS RCA WITHOUT COMPLICATION. SUBSEQUENTLY, THE STENT BECAME CLOTTED, AND THE PT SUFFERED A LATE STENT THROMBOSIS AND MYOCARDIAL INFARCTION. TREATMENT INCLUDED ADDITIONAL PCI. AS REPORTED, THE PT HAS SUFFERED HEART MUSCLE DAMAGE AND A REDUCED EJECTION FRACTION. NO PRODUCT COULD BE RETURNED FOR EVAL; IT REMAINED IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. STENT THROMBOSIS AND MYOCARDIAL INFARCTION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. WITHOUT ADDITIONAL INFO, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTE TO THIS EVENT.

    Description of Event or Problem · 1

    THIS MALE PT HAD ONE CYPHER STENT IMPLANTED IN HIS RCA IN 2003 WITHOUT COMPLICATION. SUBSEQUENTLY, THE STENT BECAME CLOTTED, AND THE PT SUFFERED A LATE STENT THROMBOSIS AND MYOCARDIAL INFARCTION. THE PT HAD TO UNDERGO RE-STENTING IN 2005. THE PT HAS SUFFERED HEART MUSCLE DAMAGE, AND A REDUCED EJECTION FRACTION.

    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