BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1210666 · Received October 23, 2008

    Report

    Report Number
    9616099-2008-02509
    Event Type
    Death
    Date Received
    October 23, 2008
    Report Date
    October 14, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COULD NOT BE RETURNED FOR EVALUATION; IT REMAINED IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. STENT THROMBOSIS AND DEATH ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY ARTERY STENTING. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL/LESION CHARACTERISTICS (LEFT MAIN BIFURCATION STENOSIS TREATED WITH A CRUSH TECHNIQUE) MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT DIED 3 DAYS POST IMPLANTATION OF A CYPHER STENT. MEDICAL HISTORY INCLUDED UNSTABLE ANGINA AND 30% LVEF. FEW DETAILS WERE AVAILABLE, ONLY THAT THE STENT WAS IMPLANTED WITH A CRUSH TECHNIQUE AND THE PATIENT WAS DISCHARGED ON DUAL ANTI-PLATELET THERAPY. THE EVENT WAS ADJUDICATED AS A PROBABLE STENT THROMBOSIS IN THE ABSENCE OF AN AUTOPSY OR ANGIOGRAPHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| L