BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1031102 · Received April 17, 2008

    Report

    Report Number
    9616099-2008-01021
    Event Type
    Injury
    Date Received
    April 17, 2008
    Report Date
    March 25, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE CYPHER SIROLIMUS-ELUTING CORONARY STENT DISTRIBUTED IN THE UNITED STATES. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE AFFILIATE INDICATING THAT LATE STENT MALAPOSITION WAS CONFIRMED ON INTRAVASCULAR ULTRASOUND (IVUS) IN SEVEN PATIENTS DURING FOLLOW-UP. THERE WERE NO CLINICAL ADVERSE EVENTS RELATED TO THIS FINDING.

    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