BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1161267 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02230
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    February 20, 2007
    Report Date
    November 26, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYPHER SELECT PRODUCT IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT.

    Description of Event or Problem · 1

    APPROXIMATELY SEVEN MONTHS POST INDEX PROCEDURE, THE PT UNDERWENT A STAGED PROCEDURE. A FOCAL INTRA-STENT STENOSIS WAS DISCOVERED AND TREATED WITH BALLOON DILATATION. THE PT WAS RANDOMIZED TO THE CLINICAL TRIAL IN 2007 FOR THREE-VESSEL CORONARY ARTERY DISEASE. A STAGED PROCEDURE WAS PLANNED FOR CARDIOVASCULAR SAFETY AFTER A DISSECTION OCCURRED DURING THE INDEX PROCEDURE (POST IMPLANTATION OF ENDEAVOR STENT IN THE LCX). THE INDICATION FOR THE INDEX PROCEDURE WAS SILENT ISCHEMIA. THE PT IS A FEMALE PT WITH A MEDICATION HISTORY CONSISTING OF HYPERTENSION, HYPERLIPIDEMIA, INSULIN CONTROLLED TYPE II DIABETES MELLITUS >20 YEARS. PRE-PROCEDURE BODY MASS INDEX (BMI) WAS REPORTED AS 44.82 AND WITH OBESITY. CHARLSON CO-MORBIDITY INDEX WAS REPORTED AS 1. LEFT VENTRICULAR EJECTION FRACTION (LVEF) WAS >50%. PRE-PROCEDURE CARDIAC ENZYMES WERE NORMAL. CREATININE WAS 0.77 MG/DL. PLATELET COUNT WAS REPORTED AT 323 AND HEMOGLOBIN AT 13.8 G/L. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE VESSEL WAS DESCRIBED AS A NATIVE CORONARY ARTERY, AND REFERENCE VESSEL DIAMETER WAS 2.5MM. LESION LENGTH WAS 33MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 70 PERCENT. POST-PROCEDURE STENOSIS WAS ZERO PERCENT. PRE AND POST-PROCEDURE TIMI FLOW IS UNKNOWN. THE LESION WAS DESCRIBED AS DENOVO, WITHOUT MAJOR SIDE BRANCH INVOLVEMENT, AND WITHOUT THROMBUS. LESION CLASSIFICATION WAS TYPE B2. THE LESION WAS PREDILATED WITH A 2.5X15MM BALLOON AT 14 ATMS; INFLATION TIME IS UNKNOWN. A 6FRENCH-GUIDING CATHETER WAS ALSO USED IN THE PROCEDURE. A 2.75X33MM CYPHER SELECT PLUS STENT WAS DEPLOYED AT 14 ATMS WITH SATISFACTORY RESULTS. POST DILATATION WAS NOT CONDUCTED. INTRAVASCULAR ULTRASOUND (IVUS) WAS NOT CONDUCTED. THE PT WAS DISCHARGED ON STATINS, BETA-BLOCKERS, 100MG OF ASPIRIN FOR SIX MONTHS, 75MG OF CLOPIDOGREL FOR SIX MONTHS AND INSULIN. PRE-PROCEDURE MEDICATIONS INCLUDED 100MG OF ASPIRIN, 75MG CLOPIDOGREL AND BETA-BLOCKERS. INTRA PROCEDURE MEDICATIONS INCLUDED UNK/MG ASPIRIN, UNK/MG OF CLOPIDOGREL, AND UNFRACTIONED HEPARIN. POST-PROCEDURE MEDICATIONS BEFORE DISCHARGE INCLUDED DAILY DOSE OF 100MG ASPIRIN, 75 MG CLOPIDOGREL AND UNFRACTIONED HEPARIN. THE PRODUCT(S) ARE NOT AVAILABLE FOR ANALYSIS. A REVIEW OF THE MANUFACTURING ROUTE SHEETS FOR THE INVOLVED LOT(S) CONFIRMED THAT THE DEVICE(S) MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. IN-STENT RESTENOSIS IS A KNOWN POTENTIAL OUTCOME OF CORONARY STENTING AND IS MULTI-FACTORIAL IN ETIOLOGY. SUBSEQUENT STENT BLOCKAGE MAY REQUIRE REPEAT DILATION OF THE STENTED AREA. WELL-KNOWN PREDICTORS ASSOCIATED WITH A HIGHER RATE OF RESTENOSIS FOLLOWING STENT IMPLANTATION INCLUDE PT FACTORS SUCH AS SEX, PRIOR HISTORY OF RESTENOSIS, DIABETES, HYPERLIPIDEMIA, HYPERTENSION, UNSTABLE ANGINA, VASOSPASTIC ANGINA, RENAL DISEASE, AND SMOKING; PROCEDURAL FACTORS SUCH AS DEVICE-TO-ARTERY RATIO, PRESENCE OF SIGNIFICANT RESIDUAL GRADIENT, SIGNIFICANT RESIDUAL STENOSIS, AND THE EXTENT OF DISSECTION; AND ANGIOGRAPHIC FACTORS SUCH AS THE SIZE OF THE REFERENCE VESSEL, SEVERITY OF THE STENOSIS, PRESENCE OF CALCIUM, ECCENTRIC LESIONS, SAPHENOUS VEIN GRAFT LOCATION, OSTIAL OR PROXIMAL LESION LOCATION, AND LEFT ANTERIOR DESCENDING LESION LOCATION, AS WELL AS CHRONIC TOTAL OCCLUSION AND LONG LESIONS. THIS PT HAS A HISTORY OF OBESITY, HYPERTENSION, HYPERLIPIDEMIA, INSULIN CONTROLLED TYPE II DIABETES MELLITUS >20 YEARS AND A PREVIOUS CORONARY ARTERY DISSECTION FOLLOWING STENT IMPLANTATION IN THE LCX. THE LESION TREATED WAS A 70%, 33MM LONG STENOSIS IN A SMALL CALIBER VESSEL (2.5MM). THESE FACTORS INCREASE THE PATIENT'S RISK FOR COMPLICATIONS FOLLOWING PCI. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR DEVICE DEFECT. THERE ARE PT, AND VESSEL/LESION, FACTORS THAT MAY HAVE CONTRIBUTED TO THIS REPORTED EVENT OF RESTENOSIS.

    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 I1106073

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R