BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 861754 · Received June 6, 2007

    Report

    Report Number
    9616099-2007-01058
    Event Type
    Injury
    Date Received
    June 6, 2007
    Date of Event
    May 10, 2007
    Report Date
    May 11, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE US DISTRIBUTED DRUG-ELUTING STENTS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT HAD AN ANTERIOR MYOCARDIAL INFARCTION, SEVEN DAYS AFTER IMPLANTATION OF A CYPHER SELECT. IT WAS A Q WAVE MI, RELATED TO THE TARGET VESSEL. PEAK VALUES ON THE DAY OF THE EVENT WERE CPK 1217, CPK-MB 88, TROPONIN 70,7. THERE WAS A 100% RESTENOSIS OF THE MAIN BRANCH, THE LEFT ANTERIOR DESCENDING BRANCH (LAD), NO THROMBUS WAS VISIBLE, TIMI FLOW WAS 0. THE SIDE BRANCH, THE 1ST DIAGONAL HAD 0% STENOSIS AND NO THROMBUS. TIMI FLOW WAS 3. PLAIN OLD BALLOON ANGIOPLASTY WAS CONDUCTED TO TREAT THE LESION. THERE WERE NO COMPLICATIONS AND THE PATIENT RECOVERED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention