BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1021188 · Received March 28, 2008

    Report

    Report Number
    9616099-2008-00807
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    January 1, 2007
    Report Date
    March 2, 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
    AS
    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. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A UNK CYPHER SELECT PLUS STENT WAS IMPLANTED INTO AN ANOMALOUS LEFT CORONARY ARTERY IN A FEMALE PT. IT LATER TRANSPIRED THAT THE WOMAN WAS ONE WEEK PREGNANT. THE PT HAD A MISCARRIAGE OF TWINS AT 12 WEEKS. PT HAD A LONG HISTORY OF TYPE I DIABETES.

    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 Life Threatening