BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1163617 · Received September 17, 2008

    Report

    Report Number
    9616099-2008-02266
    Event Type
    Injury
    Date Received
    September 17, 2008
    Report Date
    September 1, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEE, SW, PARK, SW, KIM, YH, ET AL. (2008). A RANDOMIZED COMPARISON OF SIROLIMUS-VERSUS PACLITAXEL-ELUTING STENT IMPLANTATION IN PTS WITH DIABETES MELLITUS (DES-DIABETES TRIAL). JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2008;52:727-733. 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 WILL NOT BE RETURNED. IN-STENT THROMBOSIS IS A KNOWN POTENTIAL OUTCOME OF CORONARY STENTING AND IS MULTI-FACTORIAL 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. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR ANY DEFECT OF THE DEVICE. BASED ON THE AVAILABLE INFO, IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXISTS BETWEEN THE CORDIS DEVICE, AND THE REPORTED EVENT OR WHAT CLINICAL FACTORS MAY HAVE CONTRIBUTED.

    Description of Event or Problem · 1

    AS REPORTED IN AN ARTICLE IN THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY: THIS PATIENT WITH A HISTORY OF DIABETES MELLITUS WAS ENROLLED INTO THE DES-DIABETES TRIAL AND WAS RANDOMIZED TO RECEIVE A CYPHER SIROLIMUS-ELUTING STENT. SIX HOURS POST PROCEDURE, THE PT EXPERIENCED AN ACUTE IN-STENT THROMBOSIS. THIS WAS SUCCESSFULLY TREATED WITH REPEAT INTERVENTION.

    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 UNK Hospitalization| L| R