BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1892849 · Received November 8, 2010

    Report

    Report Number
    3003742446-2010-00406
    Event Type
    Death
    Date Received
    November 8, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF THREE DEVICES USED IN THE PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2010-00404, 3003742446-2010-00405, 3003742446-2010-00406.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED FROM THE SALES REP THAT ONE HOUR POST IMPLANTATION OF THREE CYPHER STENTS IN AN (B)(6) PATIENT WHO HAD AN EJECTION FRACTION OF 30% THE PATIENT HAD A CARDIAC ARREST AND IT IS BELIEVED THAT THE PATIENT DIED. A 3.5X80 MM CYPHER STENT WAS IMPLANTED IN THE LEFT MAIN, A 3.5X8 MM CYPHER WAS IMPLANTED; HOWEVER, IT IS NOT KNOWN IF IT WAS IMPLANTED IN THE LAD OR THE CIRCUMFLEX AND A 3.0X8 MM CYPHER WAS IMPLANTED IN THE STRAIGHT CIRCUMFLEX. NO FURTHER INFORMATION REGARDING THE PRE-PROCEDURE STATUS, PROCEDURE, OR POST PROCEDURE EVENT HAS BEEN OBTAINED IN RESPONSE TO MULTIPLE INVESTIGATIVE ATTEMPTS. SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, THE FILE WILL BE READDRESSED. THE STENTS REMAIN IMPLANTED AND THE LOT NUMBERS ARE NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. BASED ON THE LACK OF INFORMATION PERTAINING TO THE PRE-PROCEDURE PATIENT STATUS, PROCEDURAL FINDINGS AND FACTORS, AND THE REPORTED POST PROCEDURE EVENT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE IMPLANTED CYPHER STENTS AND THE EVENT. HOWEVER, THE PATIENT'S BASELINE CONDITION AND UNDERLYING MEDICAL CONDITION MAY HAVE CONTRIBUTED. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF THREE DEVICES USED IN THE PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2010-00404, 3003742446-2010-00405, 3003742446-2010-00406.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD A 3.5 X 8.0 MM CYPHER STENT IMPLANTED IN THE LEFT MAIN ARTERY, A 3.5 X 8.0MM CYPHER STENT IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY/CIRCUMFLEX AND A 3.0 X 8.0MM CYPHER STENT IMPLANTED IN THE STRAIGHT CIRCUMFLEX. THE PATIENT HAD A 30% EJECTION FRACTION (EF). THE CASE WAS COMPLETED AROUND 11:00AM AND THE PATIENT CODED AROUND 12:00 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death