BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1032587 · Received April 21, 2008

    Report

    Report Number
    3003742446-2008-00062
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 25, 2008
    Report Date
    March 25, 2008
    Manufacturer
    CORDIS LLC(PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    DURING A ROUTINE CATH, A STENT FRACTURE WAS IDENTIFIED RIGHT IN THE MIDDLE OF THE STENT. THE LESION WAS IN THE NATIVE PROXIMAL RIGHT CORONARY ARTERY AND IT WAS A VERY LONG LESION. FLOW WAS NOT LIMITED. BALLOONING WAS CONSIDERED BUT A STRESS TEST WAS PERFORMED INSTEAD. THE PATIENT WILL BE BROUGHT BACK IN SIX MONTHS FOR A ROUTINE F/U. NO NEGATIVE EFFECTS TO THE PT HAVE BEEN REPORTED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR