BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1132705 · Received August 22, 2008

    Report

    Report Number
    9616099-2008-02054
    Event Type
    Death
    Date Received
    August 22, 2008
    Date of Event
    March 1, 2007
    Report Date
    August 14, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS INCLUDED IN THE STUDY AND ADMITTED THE DAY PRIOR TO THE INDEX PROCEDURE. THE PT HAD A TOTAL OF FIVE STENTS IMPLANTED IN FOUR TARGET LESIONS. FOUR CYPHER STENTS WERE IMPLANTED. TWO CYPHER 18 MM STENTS WERE IMPLANTED SUCCESSFULLY IN THE MID LEFT ANTERIOR DESCENDING (LAD) AND FIRST DIAGONAL: THE FIRST AT 10 ATM, AND THE SECOND AT 12 ATM. A CYPHER 23 MM STENT (STENT #3) WAS IMPLANTED SUCCESSFULLY IN THE POSTEROLATERAL BRANCH OF THE RIGHT CORONARY ARTERY (RCA) AT 10 ATM VIA DIRECT STENTING. AN ADD'L CYPHER 18 MM STENT (STENT #4) WAS IMPLANTED SUCCESSFULLY IN THE IMMEDIATE/ANTEROLATERAL ARTERY AT 12 ATM. THE TOTAL AMOUNT OF CONTRAST USED WAS 234 CC. THE POST-PROCEDURE CARDIAC ENZYMES WERE NORMAL. THE PT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. PLEASE NOTE THAT DEVICE (LOT # R0703476) IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PROD. THE PROD IS NOT AVAILABLE FOR EVAL AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF FOUR PRODS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT #: 9616099-2008-02052, -02053, -02054, AND 02055.

    Description of Event or Problem · 1

    THE REPORT REC'D FROM THE STUDY INDICATED THAT APPROX FORTY-MOS AFTER THE INDEX PROCEDURE, THE PT EXPIRED. THERE IS NO ADD'L INFO AT THIS TIME AS THE PT WAS NOT HOSPITALIZED AT THE STUDY SITE AT THE TIME OF HIS DEATH, NOR WAS HE HOSPITALIZED AT A LOCAL HOSPITAL. THE SITE IS CURRENTLY WAITING FOR THE DEATH CERTIFICATE. THE RELATIONSHIP OF THE EVENT TO THE STUDY DEVICES/PROCEDURE WAS NOT AVAILABLE AT THIS TIME.

    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 S0203042

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death