BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1163613 · Received September 17, 2008

    Report

    Report Number
    9616099-2008-02270
    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 RESTENOSIS 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 RESTENOSIS FOLLOWING STENT IMPLANTATION INCLUDE PATIENT FACTORS SUCH AS SEX, PRIOR HISTORY OF RESTENOSIS, DIABETES, HYPERLIPIDEMIA, HYPERTENSION, UNSTABLE ANGINA, VASOSPASTIC ANGINA, RENAL DISEASE, AND SMOKING; PROCEDURAL FACTORS SUCH AS DEVICE-TO-ARTERY RATIO, PRESENCE OF SIGNIFICANT RESIDUAL GRADIENT, SIGNIFICANT RESIDUAL STENOSIS, AND THE EXTENT OF DISSECTION; AND ANGIOGRAPHIC FACTORS SUCH AS THE SIZE OF THE REFERENCE VESSEL, SEVERITY OF THE STENOSIS, PRESENCE OF CALCIUM, ECCENTRIC LESIONS, SAPHENOUS VEIN GRAFT LOCATION, OSTIAL OR PROXIMAL LESION LOCATION, AND LEFT ANTERIOR DESCENDING LESION LOCATION, AS WELL AS CHRONIC TOTAL OCCLUSION AND LONG LESIONS. 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. DURING THE FOLLOW-UP PERIOD, THE PT EXPERIENCED STENT RESTENOSIS. NO ADDITIONAL INFO IS AVAILABLE OR FORTHCOMING.

    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