BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1003572 · Received February 25, 2008

    Report

    Report Number
    9616099-2008-00440
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    October 17, 2007
    Report Date
    January 28, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 9616099-2008-00437, 9616099-2008-00439, AND 9616099-2008-00440. CYPHER SELECT PRODUCT (CRA/CRB) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A MALE PT. THE PT'S MEDICAL CONSISTS OF A FAMILY HISTORY OF CORONARY ARTERY DISEASE AND CURRENT SMOKER. THE MAIN INDICATION FOR THE INTERVENTION WAS STABLE ANGINA PECTORIS. THE FIRST LESION TREATED WAS IN THE MID RIGHT CORONARY ARTERY. IT WAS TYPE B2, NATIVE, DE NOVO, SMOOTH, READILY ACCESSIBLE AND CONCENTRIC. THE LESION HAD A REFERENCE VESSEL DIAMETER OF 2.75 MM AND A LESION LENGTH OF 14MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 90%, PER TIMI FLOW WAS I AND POST-PROCEDURE TIMI FLOW WAS III. THE LESION WAS NOT PRE-DILATED AND A 2.75 X 18 AND A CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED. POST-PROCEDURE DIAMETER STENOSIS WAS 0. THE SECOND LESION WAS THE MID LEFT ANTERIOR DESCENDING. IT WAS TYPE C, NATIVE, DE NOVO, IRREGULAR, READILY ACCESSIBLE AND CONCENTRIC, PRE-PROCEDURE TIMI FLOW I AND POST-PROCEDURE 3. PRE-PROCEDURE DIAMETER STENOSIS 90%. THE LESION WAS PRE-DILATED. WITH A 2.75 X 12 MM BALLOON AND A CYPHER SELECT PLUS STENT 2.75 X 23 AND 2.75 X 18 WERE ELECTIVELY IMPLANTED. POST-PROCEDURE DIAMETER STENOSIS WAS 0. APPROXIMATELY ONE DAY POST INDEX PROCEDURE, THE PT EXPERIENCED A MYOCARDIAL INFARCTION NON Q-WAVE TARGET VESSEL UNDETERMINED. THE CARDIAC ENZYMES WERE ABOVE LEVEL, BUT NO MUCH. THE SECOND LESION WAS IN THE MID LEFT ANTERIOR DESCENDING (LAD). IT WAS A 90%, TYPE C, NATIVE, DENOVO, IRREGULAR, READILY ACCESSIBLE AND CONCENTRIC STENOSIS. PRE-PROCEDURE TIMI FLOW I AND POST-PROCEDURE 3. THE LESION WAS PRE-DILATED WITH A 2.75 X 12 MM BALLOON AND TWO (2) CYPHER SELECT PLUS STENTS, A 2.75 X 23 AND A 2.75 X 18, WERE ELECTIVELY IMPLANTED TO 16 ATMS. POST-PROCEDURE DIAMETER STENOSIS WAS 0. MEDICATIONS POST-PROCEDURE WERE ASPIRIN, CLOPIDOGREL, STATINS AND BETA-BLOCKERS. APPROXIMATELY ONE-DAY POST INDEX PROCEDURE, THE PT EXPERIENCED A NON Q-WAVE MYOCARDIAL INFARCTION (MI). THE AREA OF DISTRIBUTION WAS UNDETERMINED. THE CARDIAC ENZYMES WERE SLIGHTLY ELEVATED WITH MAX CK WAS 448 U/L. (PEAK CK = 2 TIMES ULN; TROPONIN < LESS THAN 2 TIMES ULN). THE MAX CK WAS 448 U/L AND THAT LEVELS WITH MINIMAL MYOCARDIAL INFARCTION. THE RELATIONSHIP TO THE CORDIS SIROLIMUS-ELUTING STENT WAS REPORTED AS UNLIKELY AND THE RELATIONSHIP TO THE INDEX PROCEDURE WAS REPORTED AS HIGHLY PROBABLE.

    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 13274009

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening 2.75 X 18 CYPHER SELECT PLUS| 2.75 X 23 CYPHER SELECT PLUS| ASPIRIN| AGGRASTAT| PLAVIX