BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1210665 · Received October 23, 2008

    Report

    Report Number
    9616099-2008-02508
    Event Type
    Death
    Date Received
    October 23, 2008
    Report Date
    October 14, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS UNKNOWN OUS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS PATIENT DIED 12 DAYS POST IMPLANTATION OF A CYPHER STENT. MEDICAL HISTORY INCLUDED UNSTABLE ANGINA AND 40% 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. 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

    AS REPORTED IN JUNE 2008, ONLINE EDITION OF THE HEART JOURNAL IN "LATE AND VERY LATE STENT THROMBOSIS FOLLOWING STENT IMPLANTATION IN UNPROTECTED LEFT MAIN CORONARY ARTERY: A MULTICENTRE REGISTRY": A PATIENT PRESENTED WITH UNSTABLE ANGINA AND 40% LEFT VENTRICULAR EJECTION FRACTION. AN UNIDENTIFIED CYPHER STENT WAS IMPLANTED IN AN UNPROTECTED DISTAL LEFT MAIN CORONARY ARTERY USING THE CRUSH TECHNIQUE. WITHIN 12 DAYS OF THE PROCEDURE, THE PATIENT DIED. THE EVENT WAS ADJUDICATED AS A PROBABLE STENT THROMBOSIS DUE TO THE ABSENCE OF AN AUTOPSY OR CONTROL ANGIOGRAPHY. THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY AT THE TIME OF THE EVENT.

    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 76 YR Death