BEUDAMED
    FDA Adverse Event Other Summary report: N

    J & J (JOHNSON & JOHNSON)

    MDR report key: 61866 · Received January 13, 1997

    Report

    Report Number
    61866
    Event Type
    Other
    Date Received
    January 13, 1997
    Date of Event
    December 20, 1996
    Report Date
    January 8, 1997
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING PTCA PROCEDURE STENT INTRODUCED BUT WAS UNDEPLOYED IN THE DISTAL LEFT MAIN CORONARY ARTERY. ALTHOUGH PT WAS CHEST PAIN FREE AND STABLE, IT WAS BEST TO PROCEED WITH BYPASS SURGERY. EMERGENCY CABG X2 WITH VEIN GRAPHS TO TEH RAMUS AND A VEIN GRAFT TO THE OM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J & J (JOHNSON & JOHNSON) Implant PALMAZ SCHATZ STENT MAF JOHNSON & JOHNSON PALMAZ SCHATZ STENT *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other