BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 58209 · Received December 17, 1996

    Report

    Report Number
    58209
    Event Type
    Other
    Date Received
    December 17, 1996
    Date of Event
    October 9, 1996
    Report Date
    November 27, 1996
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED THROUGH THE EMERGENCY DEPT IN CARDIOGENIC SHOCK WITH VENTRICULAR TACHYCARDIA & VENTRICULAR FIBRILLATION REQUIRING CARDIOVERSION X2. PT WAS TAKEN FOR EMERGENT CARDIAC CATHETERIZATION WITH LEFT VENTRICULOGRAPHY. EMERGENCY PTCA OF THE LEFT ANTERIOR DESCENDING WITH ATTEMPTED INTRACORONARY STENTING. FOLLOWING SUCCESSFUL ANGIOPLASTY, A 0.014 SPORT WIRE WAS ADVANCED DISTALLY THROUGH THE BALLOON SYSTEM AND AN ATTEMPT WAS MADE TO PASS A STENT. THE STENT PLACEMENT WAS INCOMPLETE SECONDARY TO CALIFICATION AND TORTUOSITY. THE STENT WAS LEFT IN THE PROXIMAL PORTION OF THE LEFT ANTERIOR DESCENDING. EMERGENT MYOCARDIAL REVASCULARIZATION X4 WAS PERFORMED. PT WAS DISCHARGED ON 10/17.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ-SCHATZ BALLOON-EXPANDABLE STENT WITH DELIVERY SYSTEM Implant CORONARY STENT WITH DELIVERY SYSTEM MAF NEW JERSEY PLANT NA 11681

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other