BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1030579 · Received April 14, 2008

    Report

    Report Number
    9616099-2008-00964
    Event Type
    Malfunction
    Date Received
    April 14, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 19, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OUS CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE US. HOWEVER, IT IS SIMILAR TO THE US CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADD'L INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH AN 80%, DE NOVO AND HEAVILY CALCIFIED, TYPE C LESION IN THE MID CIRCUMFLEX. THE VESSEL WAS TORTUOUS. A 2.5 X 8MM CYPHER SELECT PLUS STENT WAS IMPLANTED AT 14ATM. WHILE REMOVING THE BALLOON, IT BECAME STUCK ON THE STENT STRUTS; IT WAS CAUGHT ON THE STRUTS. THE BALLOON WAS PLACED ON NEGATIVE PRESSURE, DONE TWICE, AND IT WAS FINALLY REMOVED. IT WAS NOTED THAT WHILE TRYING TO REMOVE THE DELIVERY SYS, A MEDTRONIC GUIDING CATHETER DOVE INTO THE CIRCUMFLEX AND CAUSED A DISSECTION.

    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 13305443

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR THE PROCEDURE.| A 6F MEDTRONIC GUIDING CATHETER WAS USED DURING