BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1111904 · Received August 12, 2008

    Report

    Report Number
    9616099-2008-01974
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    June 28, 2007
    Report Date
    July 16, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA/ECG STRESS TEST/NUCLEAR SCAN. THE PT WAS REPORTED TO HAVE THREE-VESSEL DISEASE AND HAD ONE LESION TREATED DURING THE PROCEDURE. NO STAGED PROCEDURE WAS PLANNED. THE PT'S LEFT VENTRICULAR EJECTION FRACTION WAS GREATER THAN FIFTY PERCENT (LVEF>50%). THE PT'S PRE-PROCEDURE CARDIAC ENZYMES WERE ELEVATED. THE PT HAD A TOTAL OF THREE CYPHER SELECT PLUS STENTS IMPLANTED DURING THE INDEX PROCEDURE. THE TARGET LESION WAS THE SECOND DIAGONAL. THE LESION WAS REPORTED TO BE: DE NOVO, 2.5 MM VESSEL DIAMETER, 15 MM LENGTH, A 90% STENOSIS, IRREGULAR, EXCESSIVE TORTUOSITY, LOCATION IN A SEVERE BEND POINT (=>90 DEGREES), AND TYPE C. THE LESION WAS PRE-DILATED WITH A 2.0 X 15 MM BALLOON AT 10 ATM. A CYPHER SELECT PLUS 2.5 X 18 MM STENT (STENT #1) WAS IMPLANTED ELECTIVELY AT 20 ATM. THE STENT WAS POST-DILATED WITH A 2.5 X 10 M BALLOON AT 10 ATM. THE RESIDUAL STENOSIS WAS 0%. A SATISFACTORY RESULT WAS NOT OBTAINED. A CYPHER SELECT PLUS 2.25 X 18 MM STENT (STENT #2) WAS IMPLANTED AT 20 ATM DUE TO THE DISSECTION. THE STENT WAS NOT POST-DILATED AND A SATISFACTORY RESULT WAS OBTAINED. A CYPHER 2.5 X 8 MM STENT (STENT #3) WAS ELECTIVELY IMPLANTED AT 20 ATM. THE STENT WAS POST-DILATED WITH A 2.5 X 10 MM BALLOON AT 10 ATM. A SATISFACTORY RESULT WAS OBTAINED. THE THREE STENTS WERE IMPLANTED IN OVERLAPPING FASHION. THE TIMI FLOWS WERE NOT PROVIDED. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS, DEVICE DEVIATIONS OR ADVERSE EVENTS REPORTED PRIOR TO DISCHARGE. THE PT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. AT THE ONE AND TWELVE-MONTH FOLLOW-UPS, THE PT WAS ASYMPTOMATIC AND WAS CONTINUING HIS MEDICAL REGIMEN. AT THE SIX-MONTH FOLLOW-UP, THE PT WAS EXPERIENCING ANGINA AND WAS CONTINUING HIS MEDICAL REGIMEN. 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. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAY UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE STUDY INDICATED THAT APPROX ONE-YEAR AFTER THE INDEX PROCEDURE, A STAGED PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS DONE ON A CHRONIC OCCLUSION IN THE CIRCUMFLEX THAT WAS A NON-TARGET VESSEL. REVIEW OF THE DATABASE INFO INDICATED THAT DURING THE INDEX PROCEDURE, A DISSECTION OCCURRED AFTER IMPLANTATION OF A CYPHER SELECT PLUS 2.5 X 18 MM STENT IN THE SECOND DIAGONAL TARGET LESION. THE DISSECTION WAS TREATED BY IMPLANTATION OF A 2.25 X 18 MM STENT AT 20 ATM. ADDITIONAL INFO WAS REQUESTED, BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    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 13215104

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R 2.5 X 10 MM BALLOON| 6FR GUIDING CATHETER| 2.0 X 15 MM BALLOON