BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER DES

    MDR report key: 683613 · Received February 14, 2006

    Report

    Report Number
    MW1038021
    Event Type
    Injury
    Date Received
    February 14, 2006
    Date of Event
    February 8, 2006
    Report Date
    February 14, 2006
    Manufacturer
    CORDIS CORP
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED WITH ANGINA TO HAVE HEART CATH. STENT FELL OFF BALLOON DURING INSERTION INTO CORONARY ARTERY. TEMPORARY OCCLUSION OF CORONARY ARTERY REQUIRING SNARING DEVICE TO BE USED. STENT SNARED AND REMOVED FROM BODY. STENT PLACED IN PROXIMAL CIRCUMFLEX ARTERY. DISCHARGED THE NEXT DAY. PRESENTED TO THE ER FOUR DAYS LATER WITH CHEST PAIN, SINUS BRADYCARDIA AND T-WAVE INVERSIONS 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 CORP 21704 A1206017

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening