BEUDAMED
    FDA Adverse Event Death Summary report: N

    CORDIS/J & J CYPHER STENT

    MDR report key: 483362 · Received August 14, 2003

    Report

    Report Number
    483362
    Event Type
    Death
    Date Received
    August 14, 2003
    Date of Event
    August 7, 2003
    Report Date
    August 12, 2003
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD STENTS IMPLANTED INTO RCA AND IN LAD IN 2003. PT RETURNED 6 DAYS LATER WITH BOTH STENTS CLOSED AND CARDIAC ARREST WAS THE RESULT. EMERGENCY "PTCI" PERFORMED. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS/J & J CYPHER STENT CYPHER DRUG ELUTING STENT NIQ CORDIS CORPORATION CYPHER OTW 3.0MM X 23MM A0603777
    2 CORDIS CYPHER STENT CYPHER DRUG ELUTING STENT NIQ CORDIS CORPORATION CYPHER OTW 50503015

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H MEDTRONIC AVE S7 3.5MM X 9MM