BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1083542 · Received July 28, 2008

    Report

    Report Number
    9616099-2008-01864
    Event Type
    Injury
    Date Received
    July 28, 2008
    Report Date
    July 1, 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

    KANEMITSU, S., ET AL (MARCH 2008). CORONARY ARTERY BYPASS GRTING FOLLOWING IN-STENT RESTENOSIS OF DRUG-ELUTING STENTS DEPLOYED IN THE LEFT MAIN CORONARY ARTERY. CIRCULATORY JOURNAL: 72:502-504. PLEASE SEE ATTACHED JOURNAL ARTICLE. ADD'L INFO HAS BEEN REQUESTED FROM THE AUTHOR AND WILL SUBMITTED WITHIN 30 DAYS OF RECEIPT. FOREIGN CYPHER PRODUCT (CJS) IS NOT DISTRIBUTED IN THE US: HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS). THIS IS ONE OF TWO REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 9616099-2008-01863 AND 9616099-2008-01864. [SEE SCANNED PAGES.]

    Description of Event or Problem · 1

    LITERATURE ARTICLE: CORONARY ARTERY BYPASS GRAFTING FOLLOWING IN-STENT RESTENOSIS OF DRUG-ELUTING STENTS DEPLOYED IN THE LEFT MAIN CORONARY ARTERY (CASE 2 OF 2). A MAN WAS ADMITTED WITH ANGINA PECTORIS ON EFFORT. HE HAD PREVIOUSLY UNDERGONE PCI USING A DES FOR LMCAD. A CYPHER 3.0/33-MM STENT WAS DEPLOYED IN THE LMCA USING THE KISSING BALLOONING TECHNIQUE, AND A CYPHER 3.0/13MM STENT WAS DEPLOYED AT THE OSTIUM OF THE LEFT CIRCUMFLEX CORONARY ARTERY USING THE T-STENTING TECHNIQUE. CORONARY ANGIOGRAPHY 6 MONTHS AFTER PCI SHOWED IN-STENT RESTENOSIS (FIG 2). HE HAD BEEN TAKING TICLOPIDINE 200 MG DAILY AND ASPIRIN 100 MG DAILY. AS HIS CONDITION WAS STABLE, ANTIPLATELET DRUGS WERE STOPPED 5 DAYS BEFORE SURGERY. ELECTIVE OPCAB GRAFTING WAS PERFORMED WITHOUT BLOOD TRANSFUSION. THE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND POSTOPERATIVE CORONARY ANGIOGRAPHY REVEALED THAT ALL GRAFTS WERE PATENT.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R