BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001497 · Received February 19, 2008

    Report

    Report Number
    3003742446-2008-00023
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    September 15, 2004
    Report Date
    January 23, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    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

    THE PT IS A MALE WITH A HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, AND CONGESTIVE HEART FAILURE. THE PT CALLED MEDICAL AFFAIRS TO REPORT NUMEROUS ADVERSE EVENTS. THE PT WAS CONTACTED AND FURTHER CLARIFICATION WAS MADE. THE PT RECEIVED TWO CYPHERS AND AN UNK STENT IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) IN 2003. THE PT REPORTED HE EXPERIENCED TEMPORARY RELIEF OF THE PREVIOUSLY EXISTING "HEART PAIN" FOLLOWING THE PROCEDURE. THE "HEART PAIN RETURNED A FEW DAYS AFTER THE PROCEDURE, BEGINNING THE FOLLOWING MONTH. THE PT WAS READMITTED TO THE HOSPITAL AND HAD ANOTHER CYPHER IMPLANTED IN THE RCA ON THE SAME MONTH. THE PT EXPERIENCED RELIEF OF THE "HEART PAIN" FOLLOWING THE PROCEDURE. HOWEVER, THE PT HAD A RECURRENCE OF THE PAIN IN 2004 (DATE UNK) AND RECEIVED AN ADD'L CYPHER IN THE CIRCUMFLEX ARTERY (CFX) THE SAME YEAR. BEGINNING IN 2006 (DATE UNK), THE PT REPORTS THE RETURN OF THE HEART PAIN. HE WAS ADMITTED TO THE HOSPITAL IN 2004 TO HAVE ANOTHER STENT (GUIDANT MULTI-LINK) IMPLANTED IN THE CFX. THE PAIN SUBSIDED. IN 2006, THE PT HAD A RETURN OF THE CHEST PAIN AND A CAG DURING THAT YEAR SHOWED "NO PROBLEMS WITH ANY OF THE STENTS" AND "ALL THE STENTS WERE OPEN". THE PT HAS CONTINUING CHEST PAIN. PHYSICIAN IS AWARE OF THIS EVENT, NO TREATMENT HAS BEEN PRESCRIBED. A HERNIA, THE GALL BLADDER AND THE LUNGS HAVE ALL BEEN RULED OUT AS CAUSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA A0304074

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ASPIRIN| CELEBREX| CARDIZEM| MICARDIS| PLAVIX| LASIX| ZETIA| UROXATRAL