BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161264 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02224
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    January 22, 2008
    Report Date
    August 21, 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
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT REMAINS IMPLANTED IN THE PT AND WAS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE IS ONE OF THREE PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT# 9610978-2008-00231, 9616099-2008-00225. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED FOR THE STUDY INDICATED THAT A MALE UNDERWENT IMPLANTATION OF A 3.00 X 28MM CYPHER SELECT PLUS STENT IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A 3.00 X 18MM CYPHER SELECT PLUS STENT IN THE PROXIMAL CIRCUMFLEX. THE LAD WAS AN IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED PALMAZ SCHATZ STENT. AT THE SIX MONTH FOLLOW-UP IN LATE 2007, THE PT HAD ANGINA. IN EARLY 2008, THE PT COMPLAINED OF ANGINA, AN ANGIOGRAM SHOWED THAT THE STENTS IN THE CIRCUMFLEX AND LEFT ANTERIOR DESCENDING ARTERY (LAD) WERE STILL WIDELY PATENT, BUT A NEW DISEASE HAD DEVELOPED, NAMELY A CRITICAL STENOSIS IN THE DISTAL PART OF THE MAIN STEM. THE PT WAS ADVISED TO HAVE CABG. THE EVENT WAS GRADED AS UNRELATED TO THE IMPLANTED CYPHER STENTS. THE STENOSIS IN THE DISTAL LEFT MAIN WAS WITHIN 4-5MM OF THE IMPLANTED CYPHER STENTS. THIS WILL BE CAPTURED AS PERI-STENT RESTENOSIS.

    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 13185503

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R CLOPIDOGREL