BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1212544 · Received October 27, 2008

    Report

    Report Number
    9616099-2008-02530
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNTIED STATES 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 A 95% LESION IN THE MID TO DISTAL LEFT ANTERIOR DESCENDING BRANCH. THE LESION WAS HEAVILY CALCIFIED AND THE VESSEL WAS MODERATELY TORTUOUS. AFTER PRE-DILATING THE LESION, TWICE, WITH A BALLOON CATHETER, A 3.0 X 23 MM CYPHER STENT WAS DELIVERED TO THE TARGET LESION. WHILE INFLATING THE STENT DELIVERY SYSTEM TO 14 ATM, THE BALLOON RUPTURED. SINCE THE STENT WAS ALREADY DEPLOYED AT THE LESION, POST-DILATION WAS CONDUCTED WITH A DIFFERENT BALLOON. THE STENT WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PT INJURY REPORTED.

    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 13428669

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention A RUNTHROUGH GUIDEWIRE| THE FOLLOWING PRODUCTS WERE USED DURING THE| PROCEDURE:| A 3.5 X 15MM HIRYU BALLOON CATHETER.| A 7F BRITE TIP GUIDING CATHETER| A 2.5 X 15MM LACROSSE BALLOON CATHETER AND