BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS ELUTING CORONARY STENT

    MDR report key: 1091486 · Received August 1, 2008

    Report

    Report Number
    9616099-2008-01897
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    June 25, 2008
    Report Date
    July 3, 2008
    Manufacturer
    CORDIS DE MEXICO, S.A
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA. THE PT WAS FOUND TO HAVE ONE-VESSEL DISEASE AND HAD ONE LESION TREATED DURING THE INDEX PROCEDURE. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS GREATER THAN FIFTY PERCENT (LVEF>50%). AGGRASTAT WAS ADMINISTERED DURING OR AFTER THE PROCEDURE. THE TARGET LESION WAS THE FIRST OBTUSE MARGINAL (OM) BRANCH. THE LESION WAS REPORTED TO BE: DE NOVO, 3.0 MM VESSEL DIAMETER, 12 MM LENGTH, A 90% STENOSIS, A BIFURCATION LESION, IRREGULAR, ANGULATED (=>45 DEGREE AND <90 DEGREE), MODERATELY CALCIFIED, AND TYPE B2. THE LESION WAS PRE-DILATED WITH A 2.5X12 MM BALLOON AT 14 ATM. A CYPHER 3.0 X 18 MM STENT WAS IMPLANTED AT 12 ATM. THE STENT WAS POST-DILATED WITH A 2.5 X 12 MM BALLOON AT 12 ATM. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THE PATIENT'S CARDIAC ENZYMES WERE ELEVATED POST-PROCEDURE. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PT WAS REPORTED TO BE ASYMPTOMATIC AND WAS CONTINUING HIS MEDICAL REGIMEN AT THE ONE AND SIX-MONTH FOLLOW-UPS. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE STUDY INDICATED THAT APPROPRIATELY ONE-YEAR AFTER THE INDEX PROCEDURE, THE PT EXPIRED DUE TO KNOWN END STAGE LIVER CELL CARCINOMA AND WAS UNRELATED TO THE STUDY DEVICE/PROCEDURE. NO AUTOPSY WAS DONE AND THERE WAS NO REPORTED EVIDENCE OF STENT THROMBOSIS. REVIEW OF THE DATABASE INFO INDICATED THAT DURING THE INDEX PROCEDURE, THE PT HAD A TYPE B DISSECTION FLAP DISTAL TO THE CYPHER SELECT PLUS 3.0 X 18 MM STENT. THE DISSECTION WAS TREATED BY DEPLOYMENT OF AN ADD'L CYPHER SELECT PLUS 2.5 X 8 MM STENT AT 18 ATM. THE DISSECTION WAS REPORTED TO HAVE A PROBABLE RELATIONSHIP TO THE DEVICE AND WAS UNRELATED TO THE PROCEDURE OR ANY OTHER CORDIS DEVICE. THE PATIENT'S EVENT OUTCOME WAS REPORTED TO BE RESOLVED WITHOUT SEQUEL. THE PT WAS DISCHARGED TWO DAYS AFTER THE PROCEDURE.

    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, S.A NA 13197228

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R 2.5X12MM BALLOON| BMW GUIDE WIRE