BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040002 · Received May 6, 2008

    Report

    Report Number
    9616099-2008-01235
    Event Type
    Injury
    Date Received
    May 6, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 10, 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
    CA
    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. THIS DEVICE IS ONE OF THREE PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT#'S: 9616099-2008-01234, 9616099-2008-01235 & 9616099-2008-01236. 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

    A MALE PT RECEIVED 2.5 X 28MM AND 3.0 X 18MM CYPHER SELECT PLUS STENTS IN THE PROXIMAL CIRCUMFLEX IN 2008. THE MAIN INDICATION FOR THE PROCEDURE WAS ACUTE MI. THE TARGET LESION WAS AN IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED 2.5 X 13MM CYPHER STENT. IN THE SAME MONTH, THE PT WAS HOSPITALIZED WITH ACUTE PULMONARY EDEMA. ANGIOGRAM SHOWED THROMBUS IN THE 2.5 X 28MM CYPHER SELECT PLUS STENT. THE SITE ALSO INDICATED 80% RESTENOSIS IN THE PROXIMAL CIRCUMFLEX. THE PT WAS TREATED WITH A 2.5 X 18MM CYPHER STENT.

    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 13340973

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R CLOPIDOGREL| ASPIRIN