BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GFZ STENT 4.0-12

    MDR report key: 198034 · Received November 20, 1998

    Report

    Report Number
    198034
    Event Type
    Injury
    Date Received
    November 20, 1998
    Date of Event
    October 5, 1998
    Report Date
    October 15, 1998
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT SUFFERED SYNCOPAL EPISODE AT HOME AND WAS TAKEN TO AREA HOSPITAL WHERE A TEMPORARY PACEMAKER WAS PLACED. PT TRANSFERRED HERE ON 9/29 AND MONITORED IN INTENSIVE CARE UNIT. ON 9/30 A PERMANENT PACEMAKER WAS PLACED SUCCESSFULLY. PT BECAME UNSTABLE ON 10/1 AND A CARDIAC CATHETERIZATION WAS PERFORMED VIA THE LEFT BRACHIAL APPROACH. IT WAS ELECTED TO PROCEED WITH ANGIOPLASTY AND STENTING. THE PROXIMAL CIRCUMFLEX WAS PRE-DILATED WITH A 3.5/20 PREDATOR. THIS WAS DONE USING AN IVT S'PORT STENT WIRE. THEN AT ATTEMPT TO PLACE THE GFX 3.5/12 WAS MADE. THE STENT BECAME DISLODGED IN THE PROXIMAL PORTION OF THE LEFT ANTERIOR DESCENDING. THE STENT WAS LASSOED WITH A 2 MM SNARE, EXTRICATED AND WITHDRAWN BACK INTO THE BRACHIAL ARTERY RIGHT AT THE ARTERIOTOMY SITE AND COULD NOT BE WITHDRAWN FROM THERE PERCUTANEOUSLY. THE PERCUTANEOUS SITE WAS CONVERTED TO A CUT-DOWN OVER THE BRACHIAL ARTERY AND THE BRACHIAL ARTERY WAS DISSECTED OUT WHERE THE SURGEON REPAIRED THE SITE. PT WAS DISCHARGED 10/7/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GFZ STENT 4.0-12 Implant * MAF ARTERIAL VASCULAR ENGINEERING DGFW 4012 8E14E06

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention