BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER DES

    MDR report key: 680564 · Received February 23, 2006

    Report

    Report Number
    680564
    Event Type
    Injury
    Date Received
    February 23, 2006
    Date of Event
    February 13, 2006
    Report Date
    February 14, 2006
    Manufacturer
    CORDIS CORPORATION
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED WITH ANGINA TO HAVE HEART CATH. STENT FELL OFF BALLOON DURING INSERTION INTO CORONARY ARTERY. TEMPORARY OCCLUSION OF CORONARY ARTER REQUIRING SNARING DEVICE TO BE USED. STENT PLACED IN PROXIMAL CIRCUMFLEX ARTERY. DISCHARGED 2-06. PRESENTED TO THE ER IN 06 WITH CHEST PAIN, SINUS BARDYCARDIA AND T-WAVE INVERSION SUSPICIOUS OF ANTERIOR ISCHEMIA. SUBACUTE THROMBOSIS OF DES REQUIRING PLACEMENT OF NEW STENT INTO PROXIMAL CIRCUMFLEX ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER DES CARDIAC STENT NIQ CORDIS CORPORATION 21704 A120617

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening