BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLUMUS-ELUTING CORONARY STENT.

    MDR report key: 618927 · Received June 30, 2005

    Report

    Report Number
    3003742446-2005-01560
    Event Type
    Death
    Date Received
    June 30, 2005
    Date of Event
    October 7, 2004
    Report Date
    June 30, 2005
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT HAD SUFFERED AN MI WITHIN TWO WEEKS OF THE STENT PROCEDURE. THE PATIENT WAS RANDOMIZED TO THE CYPHER REGISTRY WITH A DIAGNOSIS OF UNSTABLE ANGINA. THERE WERE TWO REPORTED CORONARY LESIONS HOWEVER, ONLY ONE LESION WAS REPORTED AS BEING TREATED USING A CYPHER STENT AND NO OTHER INFORMATION WAS PROVIDED. THE REPORTED LESION WAS AT THE DISTAL CIRCUMFLEX , 76% OCCLUDED AND 17MM IN LENGTH. A (3.5 X 18MM) CYPHER STENT WAS DEPLOYED AT 10 ATMS, PRE AND POST DILATION WAS NOT DONE. PRE AND POST PROCEDURE TIMI FLOW WAS III. POST PROCEDURE STENOSIS WAS 0%. PRE PROCEDURE MEDICATIONS ARE UNKNOWN. INTRA-PROCEDURE MEDICATIONS GIVEN WERE LLB/LLA AGENT. NITROPRUSSIDE, NITROGLYCERINE, LASIX, HEPARIN AND PLAVIX. IT WAS REPORTEE THAT THIS PATIENT EXPIRES SIX MONTHS POST INDEX PROCEDURE., HOWEVER, THE EXACT CAUSE OF DEATH WAS NOT REPORTED NOR WILL THE INFORMATION BECOME AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLUMUS-ELUTING CORONARY STENT. DRUG-ELUTING STENT NIQ CORDIS LLC (PR) NA YBJ

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| O