BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2223301 · Received August 25, 2011

    Report

    Report Number
    3003742446-2011-00394
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    October 15, 2010
    Report Date
    June 27, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM MEDICAL AFFAIRS STATES THAT A PATIENT CALLED REQUESTING CORONARY STENT CARDS AND ALSO REPORTED ADVERSE EVENTS. THE PATIENT EXPERIENCED "A HEART ATTACK" IN 2005 AND HAD THREE CYPHER STENTS PLACED IN UNKNOWN CORONARY ARTERIES. THEN TEN YEARS POST INDEX PROCEDURE, THE PATIENT REPORTED "FEELING SLUGGISH" AND THE PATIENT WAS HOSPITALIZED AND HAD TWO ADDITIONAL CYPHER STENTS PLACED IN UNKNOWN CORONARY ARTERIES DUE TO "BLOCKAGE." EVENTS RESOLVED. NO FURTHER INFORMATION WAS OBTAINED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR CORONARY ARTERY DISEASE AND DIABETES. THE STERILE LOT NUMBERS FOR THE DEVICES IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WITH THE VERY LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICES AND THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFR REPORT # 3003742446-2011-00392, 3003742446-2011-00393, AND 3003742446-2011-00394.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM MEDICAL AFFAIRS STATES THAT A PATIENT CALLED REQUESTING CORONARY STENT CARDS AND ALSO REPORTED ADVERSE EVENTS. THE PATIENT EXPERIENCED "A HEART ATTACK" IN 2005 AND HAD THREE CYPHER STENTS PLACED IN UNKNOWN CORONARY ARTERIES. THEN TEN YEARS POST INDEX PROCEDURE, THE PATIENT REPORTED "FEELING SLUGGISH" AND THE PATIENT WAS HOSPITALIZED AND HAD TWO ADDITIONAL CYPHER STENTS PLACED IN UNKNOWN CORONARY ARTERIES DUE TO "BLOCKAGE." EVENTS RESOLVED. NO FURTHER INFORMATION WAS OBTAINED.

    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) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R