BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1111940 · Received August 11, 2008

    Report

    Report Number
    9616099-2008-01967
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    March 31, 2007
    Report Date
    July 15, 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
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INDICATION FOR THE INDEX PROCEDURE WAS AN ACUTE ST-ELEVATION ANTERIOR WALL MYOCARDIAL INFARCTION (STEMI) WITH ONSET OF SYMPTOMS LESS THAN SIX HOURS PRIOR TO THE PROCEDURE. THE PT 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 PATIENT'S PRE AND POST-PROCEDURE CARDIAC ENZYMES WERE ELEVATED. REOPRO WAS ADMINISTERED. THE TARGET LESION WAS THE MID CIRCUMFLEX. THE LESION WAS REPORTED TO BE: DE NOVO, 3.2 MM VESSEL DIAMETER, 20 MM LENGTH, A 100% STENOSIS, A CHRONIC TOTAL OCCLUSION/ UNKNOWN DURATION, AND TYPE C. THE LESION WAS PRE-DILATED/DETAILS NOT PROVIDED. A CYPHER SELECT PLUS 2.5X23 MM STENT WAS IMPLANTED AT 20 ATM. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE-PROCEDURE WAS TIMI 0 AND POST-PROCEDURE TIMI 3. A SATISFACTORY RESULT WAS OBTAINED. THE PT WAS DISCHARGED THREE DAYS AFTER THE PROCEDURE. THE PT WAS REPORTED TO BE ASYMPTOMATIC AT THE ONE AND SIX-MONTH FOLLOW-UP AND WAS CONTINUING HIS MEDICAL REGIMEN. PLEASE NOTE THAT DEVICE IS DISTRIBUTED OUTSIDE THE UNITES 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 THE DAY AFTER THE INDEX PROCEDURE, THE PT HAD VENTRICULAR TACHYCARDIA AT A RATE OF ONE-HUNDRED FIFTY BEATS PER MINUTE (VT/150 BPM). A BETA-BLOCKER WAS ADDED. THE EVENT DESCRIPTION STATED THAT DUE TO ATRIAL FIBRILLATION THE PT WAS TREATED WITH DIGOXIN AT BASELINE. THE DIGOXIN WAS STOPPED AND WARFARIN WAS STARTED. THE PT HAD A CYPHER SELECT PLUS STENT IMPLANTED DURING THE INDEX PROCEDURE. THE ADVERSE EVENT WAS REPORTED TO BE UNRELATED TO THE STUDY DEVICE/PROCEDURE AND THE PATIENT'S CONDITION WAS ONGOING/IMPROVED.

    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 I1106086

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R