BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053623 · Received May 23, 2008

    Report

    Report Number
    9616099-2008-01389
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    January 3, 2008
    Report Date
    April 29, 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
    FR
    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. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE MALE PT RECEIVED TWO 2.5 X 08MM CYPHER SELECT PLUS STENTS IN THE PDA, AND A 3.5 X 13MM CYPHER SELECT PLUS STENT IN THE MID RCA. DURING THE PROCEDURE, THERE WAS OCCLUSION OF A BRANCH WITHIN THE STENTED AREA IN THE MID RCA. THE SITE RELATED THIS TO THE 3.5 X 13 MM CYPHER SELECT PLUS STENT. POST PROCEDURE, THE PT HAD ELEVATED CARDIAC ENZYMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT NIQ CORDIS DE MEXICO NA 13318344

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening ASPIRIN| CLOPIDOGREL