BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1020963 · Received March 26, 2008

    Report

    Report Number
    9616099-2008-00748
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    February 15, 2006
    Report Date
    August 3, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. THIS IS ONE OF THREE REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 9616099-2008-00746, AND 9616099-2008-00749.

    Description of Event or Problem · 1

    THIS MALE PT WITH A HISTORY OF HYPERCHOLESTEROLEMIA AND SMOKING, WAS ADMITTED WITH UNSTABLE ANGINA WITHIN 48 HOURS OF MYOCARDIAL INFARCTION (CK 492/NORMAL 24-190). THE PT WAS NOT TAKING ANY MEDICATIONS AT THE TIME OF ADMISSION. HEPARIN, ASPIRIN, AND GP IIBIIIA INHIBITORS WERE ADMINISTERED DURING THE PROCEDURE. ANGIOGRAPHY REVEALED A LESION IN THE PROXIMAL CIRCUMFLEX WHICH WAS SUCCESSFULLY TREATED. THE DETAILS ARE NOT KNOWN. AN ADD'L LESION WAS NOTED WITHIN THE BIFURCATION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE DIAGONAL BRANCH. A 3.0 X 23MM CYPHER SELECT STENT WAS PLACED IN THE PROXIMAL LAD VIA DIRECT STENTING AND WAS DEPLOYED TO 15 ATMS. A 3.0 X 18MM CYPHER SELECT STENT WAS PLACED IN THE DIAGONAL BRANCH VIA DIRECT STENTING AND WAS DEPLOYED TO 15 ATMS. THE STENTS WERE POSTDILATED VIA KISSING BALLOON TECHNIQUE: A 3.0 X 20MM BALLOON WAS INFLATED TO 10 ATMS IN THE LAD AND A 2.5 X 20MM BALLOON WAS INFLATED TO 10 ATMS IN THE DIAGONAL. AN ADD'L 3.0 X 13MM CYPHER SELECT STENT WAS DEPLOYED IN THE LAD TO IMPROVE ANGIOGRAPHIC RESULTS. RESIDUAL STENOSIS POST PROCEDURE WAS 0% IN BOTH VESSELS AND THERE WAS TIMI III FLOW THROUGHOUT. POST PROCEDURE, THE PT'S ENZYMES WERE ELEVATED (CK > 5 TIMES ULN, CKMB > 5 TIMES ULN, TROPONIN I > 5 TIMES ULN). THE PT WAS RULED IN FOR ANTERIOR WALL MI. NO ADD'L ACTION WAS TAKEN. THE EVENT RESOLVED WITHIN 6 DAYS.

    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 I1205039

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening HEPARIN| ASPIRIN| 3.0 X 13MM CYPHER| GP IIBIIIA INHIBITORS| 3.0 X 23MM CYPHER| PLAVIX