BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1111955 · Received August 11, 2008

    Report

    Report Number
    9616099-2008-01957
    Event Type
    Injury
    Date Received
    August 11, 2008
    Date of Event
    May 17, 2008
    Report Date
    July 14, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN COMMENTED THAT THE POSSIBLE CAUSE OF THE THROMBOTIC EVENT WAS THAT THE PT SUFFERED CARDIAC ARREST PRIOR TO THE IMPLANTATION OF THE CYPHER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFO WAS REVIEWED FOR THROMBOSIS. VERY LATE THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. PER THE IFU THE USE OF THIS PRODUCT IS CONTRAINDICATED IN PATIENTS WHO HAD SUFFERED AN ACUTE MYOCARDIAL INFARCTION WITHIN 72 HOURS, THE ACTUAL TIME FRAME OF THE ARREST TO IMPLANT IS UNKNOWN BUT COULD POSSIBLY HAVE BEEN A FACTOR LEADING TO THE EVENT IF WITHIN THE SPECIFIED TIME FRAME. UPON REVIEW OF THE REMAINING LIMITED INFO, IT IS NOT POSSIBLE TO DETERMINE WHAT OTHER FACTORS MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM AN AFFILIATE INDICATED THAT A PT EXPERIENCED A VERY LATE THROMBOTIC EVENT AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S HISTORY IS SIGNIFICANT FOR ANGINA PECTORIS. THE INDICATING FOR THE PROCEDURE WAS CARDIAC ARREST WITH IMPLANT PERFORMED AFTER PT WAS STABILIZED WITH THE INSERTION OF A BALLOON PUMP, CARDIAC PACING AND ASPIRATION CONDUCTED. AT THAT TIME IVUS WAS CONDUCTED AND STENOSIS WAS CONFIRMED AT THE TARGET LESION, SO PCI WAS SCHEDULED. THE TARGET LESION WAS THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS ECCENTRIC AND DE NOVO WITH AN UNKNOWN PERCENT OF STENOSIS. THE LESION WAS PRE-DILATED WITH A 2.5MM X 16MM BALLOON FOLLOWED BY THE DEPLOYMENT OF A 2.5MM X 28MM CYPHER STENT; THE DEPLOYMENT AND INFLATION PRESSURES ARE UNKNOWN. THE STENT WAS SATISFACTORILY IMPLANTED, SO POST-DILATION AND IVUS WERE NOT PERFORMED. THE RESIDUAL PERCENT OF STENOSIS WAS REPORTED AS 0%. ACT WAS NOT MEASURED AND MEDICATIONS USED DURING THE PROCEDURE OR PRESCRIBED AT DISCHARGE ARE NOT KNOWN. A YEAR AND NINE DAYS LATER, THE PT COMPLAINED OF CHEST PAIN, ANGIOGRAPHY WAS PERFORMED AND THROMBUS WAS OBSERVED INSIDE THE CYPHER STENT AND PROXIMAL. ASPIRATION WAS PERFORMED TO TREAT THE EVENT.

    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 13189132

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R MEDICATIONS: ASPIRIN| HEPARIN| CLOPIDOGREL