BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER RX

    MDR report key: 521627 · Received April 16, 2004

    Report

    Report Number
    521627
    Event Type
    Death
    Date Received
    April 16, 2004
    Date of Event
    July 1, 2003
    Report Date
    November 1, 2003
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH HISTORY OF CORONARY ARTERY DISEASE, HYPERTENSION, DIABETES MELLITUS, STATUS POST, MYOCARDIAL INFARCTION IN 2003 HAD 3 STENTS TO LAD AND 1 STENT TO CIRC 4 DAYS LATER. NOT TAKING ASA SINCE THEN, BUT WAS ON PLAVIX. THE PT FELT NAUSEA, VOMITED THREE TIMES THEN FELT CHEST PAIN SUBSTERNALLY. SIX DAYS HAD PASSED AFTER THE STENTING PROCEDURE. THE PT TOOK 3 NTG WITHOUT RELIEF AND CAME TO THE ER. A CARDIAC CATH REVEALED ACUTE ANTEROLATERAL MI. ACUTE THROMBOSIS OF LAD & CIRC OM STENTS WITH CLOT. AN EXPORT THROMBECTOMY AND BALLOON ANGIOPLASTY WAS PERFORMED. THIS PT HAD RECEIVED NO STENTS PRIOR TO THIS PROCEDURE. THE PT WAS ON THE FOLLOWING MEDICATIONS PRIOR TO AND DURING THIS PROCEDURE: PRE MEDS VALIUM 10MG, ASA 325 MG AND PLAVIX 75 MG HEPARIN AND NTG/CARDENE PRIOR TO PROCEDURE AND DURING PROCEDURE ADD'L HEPARIN AND NTG/CARDENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER RX CORONARY STENT NIQ CORDIS CORPORATION CYPHER RX CXS 18300 40503741
    2 CYPHER RX CORONARY STENT NIQ CORDIS CYPHER OTWCWS18250 X0503030
    3 CYPHER RX CORONARY STENT NIQ CORDIS CYPHER RX CXS 13300 40503891
    4 CYPHER STENT CORONARY STENT NIQ CORDIS CORPORATION CYPHER OTW CWS 23250 A0503017

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| H| L| O| R