BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 589098 · Received April 5, 2005

    Report

    Report Number
    9616099-2005-00860
    Event Type
    Injury
    Date Received
    April 5, 2005
    Date of Event
    January 12, 2004
    Report Date
    April 5, 2005
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED TO THE HOSP ONE DAY BEFORE INDEX PROCEDURE WITH STABLE ANGINA ILB. THE DAY AFTER PT WAS ADMITTED, PT'S LAD PROX WAS TREATED WITH 2 CYPHER STENTS AND PT'S 1ST DIAGONAL WAS TREATED WITH 1 CYPHER STENT. THERE WAS A DISSECTION OF THE LAD (OSTIUM). THERE WAS NO REPORTED PT INJURY. A YEAR LATER PT STARTED HAVING DYSPNEA. IT WAS GRADED AS MILD. IT IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention