BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 860639 · Received May 31, 2007

    Report

    Report Number
    9616099-2007-01026
    Event Type
    Injury
    Date Received
    May 31, 2007
    Date of Event
    March 23, 2007
    Report Date
    May 2, 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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT PRESENTED TO THE CARDIAC CATHERIZATION UNIT AND THE PRIMARY INDICATION FOR TREATMENT WAS AN ACUTE MYOCARDIAL INFARCTION WITH 72 HOURS OF THE PROCEDURE AND 3-VESSEL DISEASE WAS FOUND. PRE-PROCEDURE MEDICATIONS INCLUDED ASPIRIN 100MG, CLOPIDOGREL 75MG, STATINS, AND BETA-BLOCKERS. INTRA-PROCEDURE MEDICATIONS INCLUDED ASPIRIN 300MG, CLOPIDOGREL 300MG AND UNFRACTIONED HEPARIN. PRE-PROCEDURE, CARDIAC ENZYMES WERE AS FOLLOWS: CK WAS 5 TIMES ABOVE UPPER NORMAL LIMITS, CK-MB WAS TWO TIMES ABOVE UPPER NORMAL LIMITS AND TROPONIN WAS 4 TIMES ABOVE UPPER NORMAL LIMITS. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS FIRST PERFORMED ON A 95% DE NOVO LESION IN THE OBTUSE MARGINAL OF 8MM IN LENGTH IN A 3.0MM VESSEL DIAMETER WITH THE MODERATE TORTUOSITY OF THE PROXIMAL SEGMENT. THE (B2) ECCENTRIC LESION WAS MODERATELY CALCIFIED WITH AN IRREGULAR CONTOUR AND THROMBUS ABSENT. THE LESION WAS PRE-DILATED WITH A 2.5X12MM BALLOON AT 8 ATMOSPHERES (ATM) BEFORE DEPLOYING A 2.25X8MM CYPHER SELECT STENT AT 8ATM WITH SATISFACTORY RESULTS. POST-DILATION WAS NOT DONE. THE RESIDUAL DIAMETER STENOSIS MEASURED 10%. TIMI III FLOWS WERE RECORDED PRE AND POST-PROCEDURE. POST-PROCEDURE MEDICATIONS INCLUDED PERMANENT ASPIRIN 300MG, PERMANENT CLOPIDOGREL 75MG, STATINS, ACE INHIBITORS AND BETA-BLOCKERS. POST-PROCEDURE CK AND CK-MB CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS. TROPONIN WAS 2 TIMES ABOVE UPPER NORMAL LIMITS. ONE WEEK AFTER THE PROCEDURE, THE PATIENT DEVELOPED A SKIN RASH. THERE WERE NO RESPIRATORY PROBLEMS AND THE PATIENT WAS TREATED WITH ANTIHISTAMINES. THIS WAS ONGOING AT THE 1-MONTH FOLLOW-UP. TWO WEEKS AFTER THE INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED AFTER A PROLONGED EPISODE OF CHEST PAIN. THE PATIENT'S TROPONIN WAS 0.17, ECHOCARDIOGRAM (ECG) SHOWED NON-SPECIFIC ST T WAVE CHANGES. A NON Q-WAVE MYOCARDIAL INFARCTION WAS NOTED WITH THE LOCATION UNDETERMINED. TROPONIN WAS 2 TIMES ABOVE THE UPPER NORMAL LIMITS. THERE WAS NO EVIDENCE OF STENT THROMBOSIS. THE RELATIONSHIP TO THE CYPHER STENT WAS HIGHLY PROBABLE AND THE RELATIONSHIP TO THE INDEX PROCEDURE WAS HIGHLY PROBABLE. TELEPHONE FOLLOW-UP DONE WITH THE PATIENT AT THE 1-MONTH INTERVAL. THE PATIENT REPORTED ANGINA PECTORIS. NO ADDITIONAL EVENTS WERE REPORTED OTHER THAN THE ONES ALREADY NOTED. THE PATIENT REMAINED COMPLIANT WITH TAKING ASPIRIN AS PRESCRIBED. PLEASE NOTE THAT THIS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED. THIS PRODUCT IS NOT AVAILABLE FOR TESTING AND EVALUATION. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT HAD A NON Q-WAVE MYOCARDIAL INFARCTION TWO WEEKS AFTER PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH ONE STENT.

    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 I1106052

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR