BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153065 · Received September 8, 2008

    Report

    Report Number
    9616099-2008-02184
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    December 6, 2007
    Report Date
    August 11, 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. THE PATIENT WAS FOUND TO HAVE ONE-VESSEL DISEASE AND HAD ONE LESION TREATED DURING THE PROCEDURE. NO STAGED PROCEDURE WAS PLANNED. THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS NOT PROVIDED. THE TARGET LESION WAS THE MID LAD. THE LESION WAS REPORTED TO BE: DE NOVO, 3.5 MM VESSEL DIAMETER, 14 MM LENGTH, A 90% STENOSIS, BIFURCATED, IRREGULAR, HEAVILY CALCIFIED, AND TYPE B1. ROTABLATOR WAS USED TO DEBULK THE LESION. THE LESION WAS PRE-DILATED WITH A 3.0 X 20 MM BALLOON AT 14 ATM. A CYPHER SELECT PLUS 3.5 X 33 MM STENT WAS IMPLANTED AT 14 ATM. THE STENT WAS POST-DILATED WITH A 3.5 X 15 MM BALLOON AT 18 ATM USING A KISSING BALLOON TECHNIQUE DUE TO INCOMPLETE STENT EXPANSION AND THE BIFURCATION. THE RESIDUAL STENOSIS WAS 0%. A SATISFACTORY RESULT WAS OBTAINED. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. AT THE ONE-MONTH FOLLOW-UP, THE PATIENT WAS REPORTED TO HAVE ANGINA AND WAS CONTINUING HIS MEDICAL REGIMEN. AT THE SIX-MONTH FOLLOW-UP, THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC 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 EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE STUDY INDICATED THAT DURING THE PATIENT'S INDEX PROCEDURE, A PROCEDURAL COMPLICATION OCCURRED. AFTER IMPLANTING A CYPHER SELECT PLUS 3.5 X 33 MM STENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) TARGET LESION, THE DIAGONAL BRANCH WAS NOTED TO BE PINCHED/FLOW RESTRICTED. A GUIDEWIRE WAS INSERTED INTO THE DIAGONAL BRANCH AND A KISSING BALLOON WAS USED TO DILATE THE RESTRICTION. A GOOD RESULT WAS OBTAINED.

    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 13282715

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R ROTABLATOR| 3.5 X 15MM BALLOON| 3.0 X 20MM BALLOON