BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1001491 · Received February 19, 2008

    Report

    Report Number
    9616099-2008-00376
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    September 20, 2007
    Report Date
    January 22, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. 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

    AS REPORTED BY THE STUDY, THIS PT WAS ENROLLED IN THE STUDY IN 2004. A STAGED PROCEDURE WAS PERFORMED, DURING WHICH A LESION IN THE PROXIMAL RCA WAS TREATED AND THEN TWO MONTHS LATER, A LESION IN THE MID TO PROXIMAL LAD WAS TREATED. THE PT WAS RANDOMIZED TO THE BARE METAL ARM OF THE STUDY. HOWEVER, DURING THE INDEX PROCEDURE, THREE STENTS WERE DEPLOYED. THEY INCLUDED AN EXPRESS BARE METAL STENT, A LIBERTE MONORAIL BARE METAL STENT AND A 2.75X18MM CYPHER STENT. ADDITIONAL DETAILS REGARDING THE PROCEDURE ARE NOT AVAILABLE. DURING THE THREE-YEAR FOLLOW-UP, IT WAS LEARNED THAT THE PT HAD A PCI IN 2007, AND ALSO THREE MONTHS LATER. ADDITIONAL DETAILS ARE NOT CURRENTLY KNOWN REGARDING WHICH OF THE THREE STENTS WERE ASSOCIATED WITH THESE EVENT. RELATIONSHIPS TO THE CORDIS DEVICE AND PROCEDURE WERE NOT AVAILABLE.

    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 I0704100

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R