BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032327 · Received April 21, 2008

    Report

    Report Number
    9616099-2008-01047
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    October 5, 2007
    Report Date
    March 24, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE NOT AVAILABLE FOR ANALYSIS. ADDITIONALLY, THE STERILE LOT NUMBERS ON THESE STENTS IS UNK THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED. PERI-PROCEDURAL MYOCARDIAL INFARCTION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION. WITHOUT PERTINENT INFO REGARDING VESSEL/LESION CHARACTERISTICS OR PROCEDURAL DETAILS AND ASIDE FROM INHERENT RISK OF THE PROCEDURE IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE EVENT. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2008-01045, 9616099-2008-01046.

    Description of Event or Problem · 1

    POST-PROCEDURE, THE PT HAD A INFERIOR NON-Q-WAVE MYOCARDIAL INFARCTION. PEAK CK WAS 2 TIMES ABOVE UPPER NORMAL LEVEL (UNL), PEAK CK-MB WAS GREATER THAN 5 TIMES ABOVE UNL, AND TROPONIN WAS GREATER THAN 5 TIMES ABOVE UNL. THERE WAS NO EVIDENCE OF THROMBOSIS. TWENTY FOUR HOURS POST PROCEDURE, PEAK CK WAS LESS THAN 2 TIMES ABOVE UNL, PEAK CK-MB WAS 3 TIMES ABOVE UNL, AND TROPONIN WAS GREATER THAN 5 TIMES ABOVE UNL. THE PT WAS DISCHARGED A WEEK POST PROCEDURE. THE REPORT IS FROM THE STUDY. THE PT WAS A FEMALE WITH A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, SMOKING, AND DIABETES. THE INDICATION FOR THE INDEX PROCEDURE WAS STABLE ANGINA PECTORIS. THE PT HAD A STENT PLACED IN THE DISTAL RIGHT CORONARY ARTERY (RCA), A SECOND STENT PLACED IN THE MID RCA, AND A THIRD STENT PLACED IN THE PROXIMAL RCA. THERE ARE NO FURTHER DETAILS REGARDING THE TARGET LESIONS OR INDEX PROCEDURE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening STATINS| INTEGRILIN| ASPIRIN| BIVALIRUDIN| CLOPIDOGREL