BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1063216 · Received June 17, 2008

    Report

    Report Number
    9616099-2008-01525
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    March 18, 2008
    Report Date
    May 20, 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
    CA
    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. THIS ISONE OF FOUR REPORTS FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 9616099-2008-01522, -01523, -01524, AND -01525.

    Description of Event or Problem · 1

    THIS MALE PT WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, DIABETES (RECENT ONSET), AND MODERATE TO SEVERE RENAL DISEASE WAS ADMITTED FOR CORONARY INTERVENTION. IT IS NOT KNOWN IF THE PT WAS TAKING ANY CARDIAC MEDICATIONS AT THE TIME OF ADMISSION. THE PRIMARY INDICATION FOR THE ELECTIVE PROCEDURE WAS STABLE ANGINA. DURING THE PROCEDURE, REOPRO AND HEPARIN WERE ADMINISTERED. ACT'S WERE NOT MONITORED. PRE-PROCEDURE, CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS. ANGIOGRAPHY REVEALED A DE NOVO, 95%, 13MM, IRREGULAR, ECCENTRIC, TYPE B1 LESION IN THE MID-LAD. THE LESION DIAMETER WAS 2.5MM WITH TIMI III FLOW BEYOND THE TARGET SITE. THE LESION WAS PRE-DILATED WITH A 2.0X12MM BALLOON INFLATED TO 8 ATMS. TWO CYPHER SELECT PLUS STENTS WERE IMPLANTED TO COVER THE LESION, A 2.5X23MM DEPLOYED TO 18 ATMS AND A 2.25X13MM DEPLOYED TO 18 ATMS. THE STENTS WERE POST DILATED TO ENSURE COMPLETE EXPANSION. A SECOND LESION WAS TREATED IN THE POSTERIOR DESCENDING ARTERY. THE LESION WAS A 99%, 14MM, DE NOVO, IRREGULAR, ECCENTRIC, TYPE B1 STENOSIS. THE VESSEL DIAMETER WAS 2.1MM WITH TIMI III FLOW BEYOND THE TARGET. THE LESION WAS PREDILATED WITH A 2.0X12MM BALLOON INFLATED TO 8 ATMS. A 2.25X18MM CYPHER SELECT PLUS STENT WAS DEPLOYED TO 18 ATMS. THE STENT WAS POST DILATED TO ENSURE COMPLETE EXPANSION. THE FINAL LESION TREATED WAS A 95%, 10MM, DE NOVO, IRREGULAR, ECCENTRIC, B1 TYPE STENOSIS IN THE POSTLATERAL BRANCH OF THE RCA. THE VESSEL DIAMETER WAS 2.3MM AND THERE WAS TIMI III FLOW BEYOND THE TARGET. THIS LESION WAS NOT PREDILATED. A 2.5 X 13MM CYPHER SELECT PLUS STENT WAS DEPLOYED TO 18 ATMS. THE STENT WAS NOT POST DILATED. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS. AT 6-24 HOURS POST PROCEDURE, THE PT'S CARDIAC ENZYMES WERE ELEVATED: CK>5 TIMES ULN AND TROPONIN <2 TIMES ULN. AFTER 24 HOURS, THE CARDIAC ENZYMES WERE TRENDING DOWNWARD: CK 3 TIMES ULN AND TROPONIN <2 TIMES ULN. NO ADD'L ECG WAS REPORTED AND THIS WAS NOT REPORTED AS AN MI EVENT. NO ADD'L TREATMENT WAS REQUIRED. THE PT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION. AT ONE-MONTH AND SIX-MONTH FOLLOW-UP CONTACTS, THE PT DENIED CARDIAC SYMPTOMS AND WAS COMPLIANT WITH ALL CARDIAC MEDICATIONS. 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 PRODUCTS ACCEPTANCE. THIS PATIENT HAS A HISTORY OF HYPERTENSION, DIABETES AND MODERATE TO SEVERE RENAL DISEASE. ANGIOGRAPHY REVEALED TRIPLE VESSEL CORONARY DISEASE WITH CRITICAL LESIONS IN THE MID-LAD, THE PDA AND THE PL BRANCH. ALL OF THE VESSELS TREATED WERE SMALL IN CALIBER, 2.5MM, 2.1 MM AND 2.3MM RESPECTIVELY. THESE FACTORS INCREASE THE PATIENT'S RISK OF A MAJOR ADVERSE EVENT. ALL OF THE STENTS WERE DEPLOYED TO 18 ATMS DURING IMPLANTATION, WHICH IS ABOVE THE STENT DEPLOYMENT NOMINAL PRESSURE AS WELL AS THE RATED BURST RECOMMENDED IN THE IFU. POST PROCEDURE CARDIAC ENZYMES WERE ELEVATED; HOWEVER, IS NO INFORMATION REGARDING THE PATIENT'S ECG OR CLINICAL PICTURE (ANGINA, ETC). CARDIAC ENZYMES (CK, CK-MB AND TROPONIN) ARE SENSITIVE MARKERS OF HEART MUSCLE DAMAGE AND CAN BE AFFECTED BY MULTIPLE FACTORS; HOWEVER, THESE VALUES ALONE ARE NOT SUFFICIENT TO DIAGNOSE MYOCARDIAL INFARCTION. ADD'L SIGNS AND SYMPTOMS, SUCH AS ANGINA, ECG CHANGES, OTHER VITAL SIGN MEASUREMENTS, AND THE OVERALL CLINICAL PICTURE SHOULD BE CONSIDERED TOGETHER WITH CARDIAC ENZYME LEVELS TO ESTABLISH A COMPLETE CLINICAL SYNDROME OF MYOCARDIAL INFARCTION. OTHER FACTORS THAT CAN INCREASE CARDIAC ENZYME LEVELS FOLLOWING PCI INCLUDE PROCEDURAL MANIPULATIONS WITHIN THE CORONARY ARTERIES (BALLOON INFLATION, STENT EXPANSION, ETC). UN-RECOGNIZED INTIMAL DAMAGE (MICRO-DISSECTIONS, PLAQUE RUPTURE, ETC), AND/OR CORONARY ARTERY SPASM. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A MANUFACTURING ISSUE OR ANY DEFECT OF THE DEVICE. THERE ARE PATIENT, VESSEL, LESION AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    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 13282726

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening 2.0 X 12MM BALLOON| 2.5 X 23MM CYPHER SELECT PLUS| 2.25 X 18MM CYPHER SELECT PLUS| 2.25 X 13MM CYPHER SELECT PLUS| 2.5 X 13MM CYPHER SELECT PLUS| MEDICATIONS: HEPARIN| REOPRO| PRODUCTS: 2.0 X 12MM BALLOON