BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1082255 · Received July 24, 2008

    Report

    Report Number
    9616099-2008-01847
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    October 30, 2007
    Report Date
    June 29, 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
    IT
    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 TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR. REPORT # 9616099-2008-01846. 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 RECEIVED A 3.0X23MM CYPHER SELECT PLUS IN THE PROXIMAL CIRCUMFLEX ALONG WITH 2.5 X 23MM AND 2.25 X 28MM CYPHER SELECT PLUS STENTS IN THE OBTUSE MARGINAL. POST PROCEDURE, THE PT HAD ELEVATED CARDIAC ENZYMES. THE NOTIFICATION RECEIVED FOR THE STUDY INDICATED THAT APPROXIMATELY FIVE MONTHS AFTER INDEX PROCEDURE, THE PT EXPERIENCED A POSITIVE STRESS TEST. THE PT WAS HOSPITALIZED IN ORDER TO PERFORM A CORONAROGRAPHY, WHICH SHOWED RESTENOSIS IN THE TWO CYPHER STENTS LOCATED IN THE OBTUSE MARGINAL.

    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 13197446

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R ASPIRIN| CLOPIDOGREL