BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK

    MDR report key: 119610 · Received September 11, 1997

    Report

    Report Number
    119610
    Event Type
    Death
    Date Received
    September 11, 1997
    Date of Event
    August 29, 1997
    Report Date
    September 10, 1997
    Manufacturer
    COOK CARDIOLOGY
    Product Code
    MAF
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STENT DISLODGED DURING PLACEMENT IN LAD IN CATH LAB. ATTEMPTS MADE TO REMOVE STENT AT THAT TIME WERE UNSUCCESSFUL. PT TO ICU & APPROX 1 HR LATER EXPERIENCED CHANGE IN CONDITION. PT IMMEDIATELY TAKEN TO OR IN ACUTE SHOCK. POST OP DIAGNOSIS: CARDIAC TAMPONADE, STENT DISPLACEMENT AND PERFORATED LEFT VENT. UNABLE TO REMOVE STENT DURING PROCEDURE BECAUSE "TOO FIRMLY LODGED IN THE ORIFICE OF THE LEFT MAIN ARTERY." PT DID EXPIRE 9/2/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK Implant 3.0 GR11 STENT MAF COOK CARDIOLOGY GR11 3.0 724574X

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death