BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032766 · Received April 22, 2008

    Report

    Report Number
    9616099-2008-01064
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    September 12, 2007
    Report Date
    March 25, 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
    KS
    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 IS ONE OF FOUR REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #S: 9616099-2008-01066, 9616099-2008-01067, AND 9616099-2008-01068.

    Description of Event or Problem · 1

    THIS PT WAS RANDOMIZED TO THE REGISTRY IN 2007, FOR TWO-VESSEL DISEASE. THE INDICATION FOR THE INDEX PROCEDURE WAS AN ACUTE ANTERIOR MYOCARDIAL INFARCTION (MI). THE PT WAS ADMITTED <6HOURS POST ONSET OF SYMPTOMS. THE HIGHEST KILLIP CLASS WAS I. THE PT IS A MALE WITH A MEDICAL HISTORY CONSISTING OF HYPERTENSION, DIABETES CONTROLLED WITH ORAL MEDICATIONS, MYOCARDIAL INFARCTION, AND CEREBROVASCULAR DISEASE. BASELINE MEDICATIONS INCLUDE 100MG ASPIRIN, AND 75MG CLOPIDOGREL. A BASELINE AND POST PROCEDURE ECHOCARDIOGRAM WAS PERFORMED. BASELINE HEART RATE WAS 77/MIN. BLOOD PRESSURE WAS 105/60. LEFT VENTRICULAR EJECTION FRACTION WAS <30%. PRE PROCEDURE CK WAS >5 TIMES ABOVE UPPER NORMAL LEVEL (UNL). CK-MB AND TROPONIN WERE NORMAL. MEDICATIONS AT TIME OF PCI INCLUDED 100MG ASPIRIN, 75MG CLOPIDOGREL, AND UNFRACTIONATED HEPARIN. THE FIRST TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING (LAD). THE VESSEL WAS A NATIVE CORONARY ARTERY. THIS LESION WAS TREATED WITH TWO STENTS. THE SECOND LESION WAS AT THE PROXIMAL CIRCUMFLEX AND WAS IMPLANTED WITH A THIRD STENT. THE THIRD TARGET LESION WAS AT THE LEFT MAIN AND WAS IMPLANTED WITH A FOURTH STENT NO OTHER PROCEDURAL DETAILS WERE PROVIDED. AT 6-24H POST PROCEDURE PEAK CK AND 4 TIMES ABOVE UNL, PEAK CK-MB WAS NORMAL AND TROPONIN WAS >5 TIMES ABOVE UNL. AT 24H-TO DISCHARGE PEAK CK WAS NOT DONE, PEAK CK-MB WAS NORMAL AND TROPONIN WAS >5 TIMES ABOVE UNL. CREATININE WAS 6.11MG/DL. PLATELET COUNT WAS 181. THIS WAS CONSIDERED BY THE REPORTER TO BE A "NEW" POST-PROCEDURAL MI. NO TREATMENT WAS REQUIRED. THE PT WAS DISCHARGED ON 100MG ASPIRIN, 75MG CLOPIDOGREL, LOW MOLECULAR-WEIGHT HEPARIN, INSULIN, STATINS, ACE-INHIBITORS, AND BETA-BLOCKERS. AT ONE-MONTH FOLLOW-UP, THE PATIENT REMAINED ASYMPTOMATIC AND COMPLIANT WITH THE ANTIPLATELET REGIMEN.

    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 13249108

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening HEPARIN| PLAVIX| ASPIRIN