BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1053610 · Received May 23, 2008

    Report

    Report Number
    9616099-2008-01385
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    November 6, 2007
    Report Date
    April 29, 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
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA. THE PT WAS FOUND TO HAVE ONE-VESSEL DISEASE AND HAD ONE LESION TREATED DURING THE INDEX PROCEDURE. A STAGED PROCEDURE WAS NOT PLANNED. THE MID LAD TARGET LESION WAS REPORTED TO BE: DE NOVO, 3.5 MM VESSEL DIAMETER, 15 MM LENGTH, AN 80% STENOSIS, A BIFURCATION LESION REQUIRING A DOUBLE-GUIDEWIRE TECHNIQUE, HEAVILY CALCIFIED, AND TYPE B2. A CYPHER SELECT PLUS 3.5 X 18 MM STENT WAS IMPLANTED AT 14 ATM. A PHONE CONTACT AT THE ONE-MONTH PERIOD INDICATED THE PT WAS ASYMPTOMATIC AND CONTINUING HIS MEDICAL REGIMEN. APPROX 5 MOS AFTER THE INDEX PROCEDURE, THE PT EXPIRED DUE TO LYMPHOSARCOMA THAT WAS BEING FOLLOWED CONTINUALLY BY THE PT'S ONCOLOGIST AND WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES, HOWEVER, IT IS SIMILAR TO THE UNTIED STATES PRODUCT. THE PROD IS NOT AVAILABLE FOR EVAL AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT REC'D FROM THE STUDY INDICATED THAT DURING THE INDEX PROCEDURE, A PROCEDURAL COMPLICATION OCCURRED. WHILE POST DILATING THE CYPHER SELECT PLUS 3.5 X 18 MM STENT USING A FINAL KISSING BALLOON TECHNIQUE, THE MID LEFT ANTERIOR DESCENDING (LAD) TARGET VESSEL PERFORATED. A VOYAGER 3.0 X 12 MM BALLOON WAS USED AT 25 ATM FOR POST-DILATION. THE STENT WAS POST-DILATED DUE TO THE BIFURCATION AND BECAUSE IT WAS NOT FULLY EXPANDED. THE PERFORATION WAS NOTED BY VISUALIZATION OF PARAVESSEL CONTRAST INTO THE RIGHT VENTRICLE. THE PERFORATION WAS REPORTED TO HAVE RESOLVED AFTER FIVE MINS. THE RESIDUAL STENOSIS WAS 0%. THE TIMI FLOWS WERE NOT REPORTED. A SATISFACTORY RESULT WAS NOT OBTAINED. THE EVENT WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE AND HAVE A HIGHLY PROBABLE RELATIONSHIP TO THE PROCEDURE. THE EVENT WAS MILD IN SEVERITY AND WAS NOT A SERIOUS ADVERSE EVENT (SAE). THE EVENT OUTCOME WAS COMPLETE AND THE SUBJECT'S EVENT OUTCOME WAS REPORTED TO BE RESOLVED WITHOUT SEQUEL. THE PT WAS DISCHARGED THE DAY 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 NA 13236380

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L VOYAGER 3.0 X 12 MM BALLOON