BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1071648 · Received July 8, 2008

    Report

    Report Number
    9616099-2008-01686
    Event Type
    Death
    Date Received
    July 8, 2008
    Date of Event
    April 26, 2008
    Report Date
    June 12, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. CONGESTIVE HEART FAILURE (CHF) IS A CHRONIC AND COMMON CONDITION ASSOCIATED WITH CARDIAC/ CORONARY DISEASE. THIS CONDITION OCCURS WHEN THE HEART MUSCLE (LEFT VENTRICLE) BECOMES WEAKENED AND THE HEART CAN'T PUMP ENOUGH BLOOD TO THE BODY'S OTHER ORGANS. AS A RESULT, FLUID BACK UP INTO THE PULMONARY SYSTEM CAUSING CONGESTION (PULMONARY EDEMA). CHF CAN RESULT FROM CORONARY ARTERY DISEASE, MYOCARDIAL INFARCTION, HIGH BLOOD PRESSURE, HEART VALVE DISEASE, CARDIOMYOPATHY, HEART DEFECTS, AND INFECTION OF THE HEART, AND CAN BECOME ACUTELY EXACERBATED. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DETERMINE IF A RELATIONSHIP EXITS BETWEEN THE CYPHER STENT AND THE REPORTED EVENT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS IS RELATED TO ANY MANUFACTURING ISSUE OR OTHER DEFECT OF THE DEVICE. THERE ARE POSSIBLE PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. CYPHER SELECT PRODUCT (RCA/CRB) IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED CYPHER PRODUCT (CXS).

    Description of Event or Problem · 1

    THIS MALE PATIENT WITH NO DOCUMENTED PREVIOUS HISTORY OF ILLNESS WAS ADMITTED FOR CORONARY INTERVENTION. HE WAS NOT TAKING ANY KNOWN MEDICATIONS. THE PRIMARY INDICATION FOR THE PROCEDURE WAS STABLE ANGINA. ASPIRIN, PLAVIX, AND HEPARIN WERE ADMINISTERED DURING THE PROCEDURE. THE VASP AND PFA-100 WERE MEASURED AND WERE 36% AND 240 SECONDS, RESPECTIVELY. ANGIOGRAPHY REVEALED A 70%, 13MM DE NOVO, IRREGULAR, ECCENTRIC, MODERATELY CALCIFIED LESION IN THE MID-LAD. THE LESION WAS IN THE AREA OF A BIFURCATION; THEREFORE, THE VESSELS WERE DOUBLE WIRED TO PROTECT THE SIDE BRANCH. THE VESSEL WAS 3.0MM IN DIAMETER AND WAS MODERATELY TORTUOUS IN THE PROXIMAL SEGMENT. FLOW BEYOND THE TARGET WAS TIMI III. A 3.0 X 13MM CYPHER SELECT PLUS STENT WAS POSITIONED VIA DIRECT STENTING AND WAS DEPLOYED TO 14 ATMS WITH GOOD RESULTS. RESIDUAL STENOSIS WAS 0%. THERE WERE NO REPORTED COMPLICATIONS AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION WITH ORDERS FOR DAILY ADMINISTRATION OF ASPIRIN, PLAVIX (6 MONTHS), STATINS, AND BETA-BLOCKERS. AT ONE-MONTH FOLLOW-UP, THE PATIENT DENIED CARDIAC SYMPTOMS AND WAS COMPLIANT WITH ALL MEDICATIONS. APPROXIMATELY SEVEN MONTHS POST INDEX PROCEDURE, THE PATIENT CONGESTIVE HEART FAILURE. THERE WAS EVIDENCE FOR THROMBOSIS OR MI REPORTED; HOWEVER, ANGIOGRAPHY WAS NOT CONDUCTED. CONSEQUENTLY, THE PATIENT EXPIRED. THE DEATH WAS DETERMINED TO BE CARDIAC WITH A PRIMARY CAUSE OF CONGESTIVE HEART FAILURE. NO AUTOPSY WAS PERFORMED.

    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 13258636

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death STATINS| ASPIRIN| PLAVIX (6 MONTHS)| BETA-BLOCKERS