BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1101793 · Received August 5, 2008

    Report

    Report Number
    3003742446-2008-00153
    Event Type
    Injury
    Date Received
    August 5, 2008
    Date of Event
    April 24, 2008
    Report Date
    July 10, 2008
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL, AS IT REMAINS IMPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    STENT FRACTURE. THE REPORT RECEIVED FROM THE PT, INDICATED THAT DURING THE INDEX PROCEDURE, IN 2007, THE PT RECEIVED TWO CYPHER STENTS A 2.50 X 28 MM AND A 3.50 X 13 MM. A FEW MONTHS LATER, THE PT SUFFERED AN "ANGINA ATTACK" AND WAS ADMITTED TO THE HOSP. AT THE TIME, THE PT WAS INFORMED THAT PLACEMENT OF THIRD CYPHER STENT WAS REQUIRED DUE TO THE ORIGINAL TWO CYPHER STENTS "BEING SEPARATED AND NOT OVERLAPPED"; THEREFORE, A THIRD CYPHER STENT WAS PLACED, AN INCREASED DOSAGE OF METOPROLOL WAS ADMINISTERED AND THE EVENT WAS RESOLVED. LATER, DURING A FOLLOW UP APPOINTMENT WITH THE CARDIOLOGIST, THE PT WAS INFORMED THAT THE TWO CYPHER STENTS WERE NOT SEPARATED BUT INSTEAD THE 2.50 X 28 MM CYPHER STENT HAD BEEN FOUND FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 13292693

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R