BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1030231 · Received April 16, 2008

    Report

    Report Number
    9616099-2008-01007
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 20, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 THREE PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT #'S 9616099-2008-01006 & 9616099-2008-01008. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE FEMALE PT WAS ENROLLED IN THE STUDY IN 2008. THE TARGET LESION WAS AN IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED 3.0 X 13MM CYPHER STENT THAT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA) IN 2005. THE LESION WAS TREATED WITH TWO 3.0 X 13MM CYPHER SELECT PLUS STENTS. THE DAY AFTER THE PROCEDURE, THE PT HAD INCREASE OF CK WHICH WAS REPORTED AS A MYOCARDIAL INFARCTION. THE EVENT WAS RESOLVED WITHOUT SEQUEL.

    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 13291486

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening ASPIRIN| CLOPIDOGREL