BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1222827 · Received November 3, 2008

    Report

    Report Number
    9616099-2008-02591
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    August 5, 2008
    Report Date
    October 7, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A PT WAS ADMITTED FOR ANGIOGRAPHIC CORONARY ARTERY EVAL. ANGIOGRAPHY REVEALED AN 85%, CALCIFIED STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.0 X 23MM CYPHER SELECT STENT WAS ADVANCED TO THE TARGET SITE; HOWEVER, THE STENT WOULD NOT CROSS THE CALCIFIED LESION. THE PHYSICIAN REMOVED THE DEVICE AND NOTED THAT THE TIP OF THE DELIVERY SYSTEM WAS FRAYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. UPON RECEIPT OF THE DEVICE FOR ANALYSIS, VISUAL INSPECTION REVEALED THAT THE DISTAL STRUTS OF THE STENT WERE ALSO UPLIFTED. FULL ANALYSIS OF THE DEVICE IS PENDING.

    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 13386766

    Patients

    Seq Age Sex Outcome Treatment
    1 NA