BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1003568 · Received February 25, 2008

    Report

    Report Number
    9616099-2008-00451
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 30, 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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THIS DEVICE IS ONE OF FOUR PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT#'S 9616099-2008-00448, 9616099-2008-00449, 9616099-2008-00451, & 9616099-2008-00453. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE FEMALE PT RECEIVED A 3.5 X 13 MM CYPHER SELECT PLUS STENT IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA), TWO 3.0 X 33 MM CYPHER SELECT PLUS STENTS IN THE MID RCA, AND A 2.5 X 33MM CYPHER SELECT PLUS STENT IN THE DISTAL RCA. A DAY AFTER THE PROCEDURE, THE PT HAD ANGINA AND ELEVATED ENZYMES WHICH WERE REPORTED AS A MYOCARDIAL INFARCTION (MI). ANGIOGRAPHY REVEALED THROMBOSIS IN THE IMPLANTED STENTS. THE PT WAS TREATED WITH A 3.5 X 13MM CYPHER SELECT PLUS STENT.

    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 13278386

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention ASPIRIN| CLOPIDOGREL