BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1212535 · Received October 27, 2008

    Report

    Report Number
    9616099-2008-02535
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 3, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THREE AND A HALF YRS POST PROCEDURE, THE PT COMPLAINED OF CHEST PAIN AND WAS ADMITTED TO THE HOSP. DURING THE CORONARY ANGIOGRAM A THROMBUS WAS OBSERVED IN THE IMPLANTED CYPHER STENT AT THE LEFT ANTERIOR DESCENDING ARTERY. THE THROMBUS WAS ASPIRATED AND THE PT HAD POBA USING AN ANGIOSCULPT 3.0 X 20 MM BALLOON SEVERAL TIMES AT AN UNK ATM AND NUMBER OF TIMES. THE NEXT DAY THE PT WAS TRANSFERRED TO ICU AND HIS CONDITION WAS REPORTED AS STABLE. THE PHYSICIAN COMMENTED THAT POSSIBLY THE CAUSE OF THE THROMBOTIC EVENT WAS BECAUSE HE STOPPED ADMINISTRATING TICLOPIDINE HYDROCHLORIDE AND CHANGED THE DOSE OF ASPIRIN FROM 200 MG/DAY TO 100 MG/DAY, DUE TO THE SIX MOS PASSED AFTER THE CYPHER STENT WAS IMPLANTED. INDEX PROCEDURE: THIS WAS AN EMERGENCY PROCEDURE DUE TO THE ACUTE MYOCARDIAL INFARCTION (AMI). THE LESION WAS LEFT ANTERIOR DESCENDING ARTERY, ECCENTRIC, BIFURCATED AND TOTALLY OCCLUDED, TYPE "C". THE LESION LENGTH WAS 25 MM AND THE VESSEL DIAMETER WAS 3.0MM. THE LESION WAS PRE-DILATED USING A 2.5 X 20 MM BALLOON AT 20 ATM FOR 45 SECONDS. THEN A CYPHER 3.2 X 28 MM WAS IMPLANTED AT 12 ATM FOR 30 SECONDS. POST DILATATION WAS CONDUCTED USING A 3.5 X 15 MM BALLOON AT 20 ATM FOR 30 SECONDS. IVUS WAS CONDUCTED; THE RESIDUAL PERCENTAGE OF THE STENOSIS WAS 0%. TIMI FLOW BEFORE THE PROCEDURE WAS (0) AND (3) AFTER THE PROCEDURE. ACT WAS NOT MEASURED.

    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 I0105003

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R