BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER STENT

    MDR report key: 503031 · Received December 16, 2003

    Report

    Report Number
    MW1030620
    Event Type
    Injury
    Date Received
    December 16, 2003
    Date of Event
    November 24, 2003
    Report Date
    December 16, 2003
    Manufacturer
    CORDIS
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH EVOLVING INFERIOR MI. PREVIOUS ANGIOGRAM SHOWED 100% OBSTRUCTED LAD AND 90% RCA. LAD WAS NOT TACKLED AND A CYPHER STENT WAS PUT IN RCA. PT WAS BROUGHT WITH CHEST PAIN TO HOSP. REPEAT ANGIOGRAM SHOWED COMPLETELY BLOCKED RCA. ACUTE STENT OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER STENT CORONARY STENT NIQ CORDIS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R