BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1213925 · Received October 28, 2008

    Report

    Report Number
    9616099-2008-02542
    Event Type
    Death
    Date Received
    October 28, 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

    THE PRODUCT IS NOT AVAILABLE FOR ANALYSIS. ADDITIONALLY, THE STERILE LOT NUMBER IS NOT KNOWN. NO FURTHER ANALYSIS CAN BE PERFORMED FOR COMPLAINTS REPORTED WITHOUT A LOT NUMBER AND FOR WHICH THE ASSOCIATED PRODUCTS WILL NOT BE RETURNED. IN-STENT THROMBOSIS IS A KNOWN POTENTIAL OUTCOME OF CORONARY STENTING AND IS MULTIFACTORIAL IN ETIOLOGY. SUBSEQUENT STENT BLOCKAGE MAY REQUIRE REPEAT DILATION OF THE STENTED AREA. WELL-KNOWN PREDICTORS ASSOCIATED WITH A HIGHER RATE OF THROMBOTIC EVENTS (ACUTE, SUB-ACUTE, AND LATE) FOLLOWING STENT IMPLANTATION INCLUDE PHARMACOLOGICAL FACTOR SUCH AS DISCONTINUATION OF ANTIPLATELET THERAPY BEFORE SIX MONTHS; ANGIOGRAPHIC FACTORS SUCH AS LONG LESIONS, MULTIPLE STENTS, CALCIFIED LESIONS AND SMALL VESSELS; PATIENT-RELATED FACTORS SUCH AS ACUTE PRESENTATION, SMOKING AND CONGESTIVE HEART FAILURE; AND PROCEDURAL FACTORS SUCH AS INADEQUATE POST-PROCEDURE LUMEN DIMENSIONS, DISSECTION, THROMBUS, AND TISSUE PROLAPSE. SIGNIFICANT STENT THROMBOSIS PREDICTORS BEYOND ONE YEAR (VERY LATE) CONSIST OF MORE BIOLOGIC FACTORS, INCLUDING FAILED BRACHYTHERAPY, CHRONIC TOTAL OCCLUSIONS, PRIOR MYOCARDIAL INFARCTION AND PATIENT AGE. BASED ON THE AVAILABLE INFO IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE DEVICE AND THE REPORTED EVENT. THERE ARE MULTIPLE PATIENT, VESSEL, LESION, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED THROMBOTIC EVENT. THIS CYPHER PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT.

    Description of Event or Problem · 1

    AS REPORTED IN THE JUNE 2008, ONLINE EDITION OF THE EUROPEAN HEART JOURNAL IN "LATE AND VERY LATE STENT THROMBOSIS FOLLOWING STENT IMPLANTATION IN UNPROTECTED LEFT MAIN CORONARY ARTERY: A MULTICENTRE REGISTRY: A PT PRESENTED WITH A 28% LVEF AND UNSTABLE ANGINA. AN UNIDENTIFIED CYPHER STENT WAS DEPLOYED IN AN UNPROTECTED LEFT MAIN CORONARY ARTERY DISTAL LESION USING THE CRUSH TECHNIQUE. AT 154 DAYS AFTER OF THE PROCEDURE, THE PT DIED. THE EVENT WAS ADJUDICATED AS A POSSIBLE STENT THROMBOSIS DUE TO HE ABSENCE OF AN AUTOPSY OR CONTROL ANGIOGRAPHY. THE PT WAS NOT ON DUAL ANTIPLATELET THERAPY AT THE TIME OF THE EVENT. CHEIFFO, A, ET AL 2008. LATE AND VERY LATE THROMBOSIS FOLLOWING DRUG-ELUTING STENT IMPLANTATION IN UNPROTECTED LEFT MAIN CORONARY ARTERY: A MULTICENTRE REGISTRY. EUROPEAN HEART JOURNAL; 29, PP 2108-2115.

    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 82 YR Hospitalization| L| R