BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER-SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 621197 · Received June 6, 2005

    Report

    Report Number
    MW1035648
    Event Type
    Death
    Date Received
    June 6, 2005
    Date of Event
    February 11, 2005
    Report Date
    May 25, 2005
    Manufacturer
    CORDIS J & J
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO HOSP ON 2005 FOR AN ELECTIVE ANGIOGRAM WITH POSSIBLE ANGIOPLASTY DUE TO POSSIBLE LARGE BLOCKAGE AFTER ARTERIAL SCREENING AND STRESS TEST. PROOF OF EXCELLENT PHYSICAL HEALTH THRU INTERNIST (CD-ROM GIVEN WITH CONTROLLED CHOLESTEROL, BLOOD PRESSURE & WEIGHT.) ON RELATED MEDS FOR MANY YEARS. PT SHOWED SOME SIGNS OF PROBLEM WHILE ANGIOPLASTY WAS BEING PERFORMED. PT WAS RELEASED THE NEXT DAY TO HOME WAS GIVEN PRESCRIPTION WITH 75 MG PLAVIX 1 TIME A DAY WITH FULL STRENGTH 325MG ASPIRIN WHICH PT COMPLIED WITH. TWO DAYS LATER RE-ADMITTED TO SAME HOSP WITH SIGNS OF HEART ATTACK. DX CORONARY THROMBOSIS OPERATING ROOM CLOT DIAGNOSED NEXT TO IMPLANTED CYPHER STENT. COLT REMOVED. 1 NEW CYPHER STENT IMPLANTED ONE NEXT TO THE OTHER. PT RELEASED TO ICU FOR TWO DAYS. RELEASED HOME WITH EXACT PRESCRIPTIONS AS BEFORE (PLAVIX AND ASPIRIN) PT COMPLIED WITH THIS COMPLETELY. PT WENT HOME TWO DAYS LATER IN AFTERNOON WITHIN HALF AN HOUR OF PT GETTING HOME BEGAN HAVING MILD PRESSURE CHEST AREA AND ARM. PT COLLAPSES AT HOME OF HEART ATTACK (CORONARY THROMBOSIS). CPR DONE AND 911 EMERGENCY TEAM UNABLE TO REVIVE. PT PRONOUNCED DEAD AT HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER-SIROLIMUS-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ CORDIS J & J RXCXS 13300 3.00MMX13MM 41104544

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H