BEUDAMED
    FDA Adverse Event Other Summary report: N

    J & J (JOHNSON AND JOHNSON)

    MDR report key: 194705 · Received October 30, 1998

    Report

    Report Number
    194705
    Event Type
    Other
    Date Received
    October 30, 1998
    Date of Event
    July 29, 1998
    Report Date
    October 30, 1998
    Manufacturer
    JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS CO.
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CONTINUED WITH ANGINA. FOUND TO HAVE LESION IN RIGHT CORONARY ARTERY: ATTEMPT WAS MADE AT BALLOON DILATATION & STENTING. THE STENT BECAME DISLODGED AND WAS ABLE TO BE DEPLOYED IN THE APPROPRIATE PLACE, PLUS THE GUIDE-WIRE BECAME ENTANGLED IN THE STENT. PT WAS TAKEN FOR EMERGENCY CORONARY ARTERY BYPASS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J & J (JOHNSON AND JOHNSON) Implant PALMAZ SCHATZ STENT MAF JOHNSON & JOHNSON INTERVENTIONAL SYSTEMS CO. * A0698809

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other