BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1063220 · Received June 17, 2008

    Report

    Report Number
    3003742446-2008-00111
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    December 10, 2004
    Report Date
    May 21, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD 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 PRODS 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 RESULT IN MYOCARDIAL ISCHEMIA AND/OR INFARCTION AND MAY REQUIRE REPEAT DILATION OF THE STENTED AREA. WELL-KNOWN PREDICTORS ASSOCIATED WITH A HIGHER RATE OF THROMBOTIC EVENTS INCLUDE PHARMACOLOGICAL FACTORS, SUCH AS DURATION OF ANTIPLATELET THERAPY; ANGIOGRAPHIC FACTORS SUCH AS LONG LESIONS, MULTIPLE STENTS, CALCIFIED LESIONS AND SMALL VESSELS; PT RELATED FACTORS SUCH AS CLINICAL PRESENTATION (ACUTE OR STABLE) AND MEDICAL HISTORY (PROGRESSIVE VASCULAR DISEASE, DIABETES, PREVIOUS MI, PREVIOUS CORONARY INTERVENTIONS, AND SMOKING); AND PROCEDURAL FACTORS SUCH AS INADEQUATE POST-PROCEDURE LUMEN DIMENSIONS, DISSECTION, THROMBUS, AND TISSUE PROLAPSE. SIGNIFICANT STENT THROMBOSIS PREDICTORS BEYOND ONE YR (VERY LATE) CONSIST OF MORE BIOLOGIC FACTORS, INCLUDING FAILED BRACHYTHERAPY, CHRONIC TOTAL OCCLUSIONS, PRIOR MYOCARDIAL INFARCTION, PROGRESSION OF KNOWN DISEASE, AND PT AGE. BASED ON THE AVAILABLE INFO, IT IS NOT POSSIBLE TO DETERMINE IF A CAUSAL RELATIONSHIP EXISTS BETWEEN THE PROD AND THE REPORTED EVENTS. THERE ARE MULTIPLE PT , VESSEL, LESION, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED. THIS IS ONE OF THREE REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 3003742446-2008-00109, 3003742446-2008-00110 AND 3003742446-2008-00111.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| R