BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 694120 · Received March 29, 2006

    Report

    Report Number
    9616099-2006-00338
    Event Type
    Injury
    Date Received
    March 29, 2006
    Date of Event
    March 21, 2006
    Report Date
    March 29, 2006
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY THREE DAYS POST INDEX PROCEDURE THE PATIENT COMPLAINED OF CHEST PAIN AND CAG WAS CONDUCTED, WHERE THROMBUS WAS OBSERVED IN THE OVERLAPPING PORTION OF THE CYPHER STENTS IMPLANTED AT 1ST DIAGONAL BRANCH AND THE PROXIMAL AND MID LAD. TO TREAT THE THROMBUS ASPIRATION WAS CONDUCTED AND POBA WAS CONDUCTED BY THE KBT WITH A 3.015MM BALLOON AT 8 ATM FOR 20 SECONDS TWICE AT THE PROXIMAL AND MID LAD. THE PATIENT WAS PLACED ON INTRA AORTIC BALLOON PUMP.

    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 UNKNOWN Hospitalization| L| R