BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1212594 · Received October 24, 2008

    Report

    Report Number
    9616099-2008-02517
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    April 30, 2004
    Report Date
    September 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROD REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT. THIS DEVICE IS ONE OF TWO PRODUCTS ASSOCIATED WITH THIS EVENT. PLEASE REFER TO MFR REPORT # 9616099-2008-02519.

    Description of Event or Problem · 1

    THE FEMALE PT REC'D TWO 3.0 X 13 MM CYPHER STENTS AND ONE 3.0 X 18 MM CYPHER STENT TO TREAT LESIONS IN THE DISTAL CIRCUMFLEX AND THE PROXIMAL LAD IN 2003. PT WAS HOSPITALIZED ON JULY 28, 2008 WITH AN MI. EVIDENCE OF ST-ELEVATION AND POSITIVE TROPONIN (1.7 NG/ML). CK VALUE: 677 IU/L, CK-MB: 107 IU/L. THE DIAGNOSTIC IS: LATERAL MI. ONLY CONSERVATIVE TREATMENT. NO EVIDENCE OF ISCHEMIA ON THE STRESS TEST. BLOOD PRESSURE: 192/82 MMHG, BEAT: 112 BPM. PT DISCHARGED IN GOOD CONDITIONS ON FIVE DAYS LATER.

    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 R0203380

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R