BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001486 · Received February 19, 2008

    Report

    Report Number
    9616099-2008-00382
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    November 18, 2007
    Report Date
    January 23, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT ENROLLED IN THE STUDY FOR 1-VESSEL DISEASE. THE MAIN INDICATION FOR THE INTERVENTION WAS AN INFERIOR ACUTE MYOCARDIAL INFARCTION. THE LESION INITIALLY TREATED WAS IN THE FIRST OBTUSE MARGINAL BRANCH. IT WAS TYPE B1, NATIVE, DE NOVO, SMOOTH, READILY ACCESSIBLE AND CONCENTRIC. THE LESION HAD A REFERENCE VESSEL DIAMETER OF 2.5MM AND A LESION LENGTH OF 18MM. PRE-PROCEDURE DIAMETER STENOSIS WAS 80%. A 2.5 X 23MM CYPHER SELECT PLUS STENT WAS ELECTIVELY IMPLANTED AT 16ATM WITH SATISFACTORY RESULTS. THE STENT WAS NOT POST-DILATED. POST-PROCEDURE DIAMETER STENOSIS WAS ZERO. FORTY-SIX DAYS POST INDEX PROCEDURE, THE PATIENT HAD ANGIOGRAPHY DONE DUE TO ANGINA PECTORIS. MEDICAL TREATMENT WAS REQUIRED. DURING THE ONE-MONTH FOLLOW-UP PHONE CALL, TO THE PATIENT, IN 2007, THE PATIENT WAS ASYMPTOMATIC. THE MEDICATION TREATMENT OF ASPIRIN, CLOPIDOGREL, STATINS AND BETA-BLOCKERS WAS ONGOING. SIX-MONTH FOLLOW-UP INFORMATION, RECEIVED ON JULY 19, 2007, FROM THE REFERRING CARDIOLOGIST INDICATED THAT THE PATIENT HAD ANGINA PECTORIS. THE MEDICATION TREATMENT OF ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS WAS ONGOING. APPROXIMATELY TEN MONTHS POST INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED FOR "A LAPAROSCOPIC NEFRECTOMIA LEFT AND AN PYELO-URETERECTOMIA FOR A CARCINOMA; DISCHARGED IN GOOD CONDITION". THIS EVENT WAS GRADED AS SEVERE AND WAS DEEMED TO BE UNRELATED TO ANY CORDIS PRODUCT. THE EVENT WAS RESOLVED WITHOUT SEQUEL. DURING A ONE-YEAR FOLLOW-UP PHONE CALL, TO THE PATIENT, THE PATIENT WAS ASYMPTOMATIC. THE MEDICATION TREATMENT OF ASPIRIN, CLOPIDOGREL, STATINS, ACE INHIBITORS AND BETA-BLOCKERS WAS ONGOING. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. ANY ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM REGISTRY INDICATING THAT APPROXIMATELY TEN MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI) FOLLOWING NEPHRECTOMY DUE TO CARCINOMA. THE LOCATION OF THE MI WAS UNDETERMINED. THIS EVENT WAS GRADED AS MILD IN SEVERITY AND WAS DEEMED TO BE UNRELATED TO ANY CORDIS PRODUCT. THE EVENT WAS RESOLVED WITHOUT SEQUEL.

    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 I1006009

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR