BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1153443 · Received September 5, 2008

    Report

    Report Number
    9616099-2008-02169
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    December 18, 2007
    Report Date
    December 20, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MDR REPORT # 9616099-2008-00124. THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT CXS 13275. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE MALE PT WAS ENROLLED IN THE STUDY. THE TARGET LESION WAS LOCATED IN THE DISTAL RCA. THE LESION WAS DE NOVO AND NOT OSTIAL. THE VESSEL WAS CLASSIFIED AS TYPE B2. THE MAIN INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE VESSEL WAS NOT PREDILATED. A 2.75 X 13MM CYPHER SELECT PLUS STENT WAS IMPLANTED AT 16 ATM WITH SATISFACTORY RESULTS. NO POSTDILATION WAS NECESSARY. A 3.0 X 23MM CYPHER SELECT PLUS STENT WAS THEN IMPLANTED AT 18 ATM. POSTDILATION WAS CONDUCTED FOR THIS STENT BECAUSE THERE WAS INSUFFICIENT FLOW. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. APPROXIMATELY ONE YEAR POST PROCEDURE IN EARLY 2008, THE PT HAD A NON Q WAVE MI WITH LIKELY STENT THROMBOSIS. MI LOCATION WAS INFERIOR, NO RE-PCI WAS CONDUCTED. ON FIVE MONTHS LATER, THE PT HAD ANGINA.

    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 13271851

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R CLOPIDOGREL| ASPIRIN