BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1715771 · Received June 10, 2010

    Report

    Report Number
    3003742446-2010-00191
    Event Type
    Death
    Date Received
    June 10, 2010
    Date of Event
    April 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS IT WAS REPORTED IN A ARTICLE FOUND IN A MEDICAL JOURNAL A PATIENT EXPERIENCED SUB-ACUTE STENT THROMBOSIS AND DIED SEVEN DAYS AFTER HAVING A CYPHER STENT IMPLANTED. THE PATIENT WAS A HEART TRANSPLANT RECIPIENT WITH A HISTORY OF CARDIAC ALLOGRAFT VASCULOPATHY. CARDIAC ALLOGRAFT VASCULOPATHY (CAV) REMAINS A TROUBLESOME LONG-TERM COMPLICATION OF HEART TRANSPLANTATION. IT IS MANIFESTED BY A UNIQUE AND UNUSUALLY ACCELERATED FORM OF CORONARY DISEASE AFFECTING BOTH INTRAMURAL AND EPICARDIAL CORONARY ARTERIES AND VEINS. THERE IS NO OTHER INFORMATION AVAILABLE. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE, A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. SUB-ACUTE STENT THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. WITH THE VERY LIMITED INFORMATION PROVIDED. IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: LEE, MICHAEL S. ET AL,(APRIL 2010) "SIROLIMUS-VERSUS PACLITAXEL-ELUTING STENTS FOR THE TREATMENT OF CARDIAC ALLOGRAFT VASCULOPATHY" JACC: CARDIOVASCULAR INTERVENTIONS VOL. 3 (2010), PP 378-382. THE CATALOG NUMBER PROVIDED (CXSXXX) REPRESENTS A UNKNOWN CYPHER STENT. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS IT WAS REPORTED IN A MEDICAL JOURNAL ARTICLE, SUBACUTE STENT THROMBOSIS OCCURRED IN A PATIENT THAT RECEIVED A CYPHER STENT. THE PATIENT DIED SUDDENLY 7 DAYS POST-PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK TESTING ON THE SAME METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS OF 246MG/DL AND 81MG/DL. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    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 Death