BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1002356 · Received February 22, 2008

    Report

    Report Number
    9616099-2008-00429
    Event Type
    Death
    Date Received
    February 22, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CYPHER SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. THIS IS ONE OF TWO PRODUCTS INVOLVED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING NUMBERS 9616099-2008-00429 AND 9616099-2008-00430. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A REPORT RECEIVED FROM INDIA INDICATED THAT A PATIENT DIED FROM NEUROLOGICAL COMPLICATIONS WITHIN FIVE DAYS AFTER RECEIVING TWO CYPHER STENTS. THE MAIN INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA. TARGET VESSELS WERE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE RCA WAS 80% STENOSED AND LAD WAS 85% STENOSED. BOTH VESSELS WERE PRE DILATED AND TWO CYPHER STENTS WERE DEPLOYED AT 16 ATMS EACH TO TREAT THE LESIONS. IT IS NOT KNOWN WHICH STENT WAS DEPLOYED IN WHAT VESSEL. POST DILATATION WAS NOT CONDUCTED AND THE PATIENT WAS ON ANTIPLATELET THERAPY. IT WAS REPORTED THAT THE PATIENT DIED OF INTRACRANIAL HEMORRHAGE WITHIN FIVE DAYS AFTER IMPLANTATION OF THE CYPHER STENTS. AN AUTOPSY WAS NOT DONE.

    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 13306041

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death UNKNOWN ANTIPLATE THERAPY