BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1040533 · Received May 9, 2008

    Report

    Report Number
    9616099-2008-01271
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    September 7, 2007
    Report Date
    April 15, 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
    EI
    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 #9616099-2008-01273. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE MALE PT REVIEWED TWO CYPHER SELECT STENTS TO TREAT LESIONS IN THE PROXIMAL TO MID LAD IN 2007. A DAY AFTER THE PROCEDURE, THE PT HAD POSITIVE TROPONIN REPORTED AS A NON Q-WAVE MI IN AN UNDETERMINED LOCATION ALONG WITH "CHEST FULLNESS". A NITRATE PATCH WAS APPLIED. PT WAS DISCHARGED HOME THE NEXT DAY. ON APPROX TWO MONTHS LATER, THE PT HAD ANGINA PECTORIS. AT THE SIX MONTH FOLLOW UP IN 2008, THE PT HAD ANGINA PECTORIS.

    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 13252532

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening| R CLOPIDOGREL| ASPIRIN