BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER

    MDR report key: 1002185 · Received January 28, 2008

    Report

    Report Number
    1002185
    Event Type
    Malfunction
    Date Received
    January 28, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 18, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WANTED TO REPORT AN ADVERSE AFFECT FROM A STENT PLACEMENT IN A PATIENT. THE PATIENT HAD A DRUG-ELUTING STENT PLACED IN TWO YEARS AGO. OVER TIME, THE PATIENT BEGAN TO HAVE CONTINUED CHEST DISCOMFORT. THE PATIENT'S MEDICATIONS WERE MAXIMIZED; HOWEVER, THE SYMPTOMS PERSISTED. THE PATIENT UNDERWENT DIAGNOSTIC, ANGIOGRAPHY AND ULTRASOUND PROCEDURES APPROXIMATELY NINE MONTHS LATER, WHICH SHOWED THE VESSEL TISSUE BEFORE AND AFTER THE STENT HAD DEVELOPED AN ANEURYSM. BECAUSE OF PERSISTENT SYMPTOMS, THE PATIENT WAS REFERRED AGAIN THIS YEAR FOR ULTRASOUND TO DETERMINE DEFINITIVE THERAPY. THE PATIENT IS CURRENTLY BEING ADMITTED FOR HEART BYPASS SURGERY. THE PHYSICIAN BELIEVES THIS COULD BE A DEVICE ISSUE, AS THE STENT WAS PLACED PERFECTLY AND IS STILL WELL APPOSED TODAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER STENT, DRUG-ELUTING NIQ CORDIS CORPORATION CXS18275 50106309

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR