BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1071576 · Received July 7, 2008

    Report

    Report Number
    9616099-2008-01683
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 12, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S HISTORY IS SIGNIFICANT FOR HYPERTENSION, HYPERLIPIDEMIA AND PRIOR HISTORY OF SMOKING. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE INTENDED TARGET WAS THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD). VESSEL/LESION CHARACTERISTICS AS WELL AS PROCEDURAL DETAILS ARE NOT AVAILABLE. A 3.0MM X 13M AND A 2.50 MM X 33MM CYPHER SELECT PLUS STENT WERE IMPLANTED IN THE PROXIMAL AND MID LAD. THE PATIENT EXPERIENCED A PROCEDURAL NON-Q-WAVE, ANTERIOR MYOCARDIAL INFARCTION RELATED TO THE INCIDENTAL OCCLUSION OF THE SECOND DIAGONAL ARTERY BRANCH. THE DETAILS REGARDING THE SIDE BRANCH OCCLUSION ARE UNAVAILABLE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. MYOCARDIAL INFARCTION FOLLOWING THE OCCLUSION OF A SIDE BRANCH IS A KNOWN POTENTIAL ADVERSE EVENT RELATED TO HAVING A CORONARY STENT IMPLANTED. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THIS IS ONE OF TWO PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MANUFACTURING REPORT #: 9616099-2008-01682. 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 INDICATED THAT A PATIENT EXPERIENCED A MYOCARDIAL INFARCTION RELATED TO SIDE BRANCH OCCLUSION WHILE HAVING CORONARY STENTS IMPLANTED.

    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 13385253

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L