BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 220135 · Received April 23, 1999

    Report

    Report Number
    2953200-1999-00036
    Event Type
    Injury
    Date Received
    April 23, 1999
    Date of Event
    March 24, 1999
    Report Date
    March 26, 1999
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 4.0MM DIAMETER X 24MM LENGTH AVE GFX STENT WAS SUCCESSFULLY PLACED AT A TOTALLY OCCLUDED TARGET LESION IN THE RIGHT CORONARY ARTERY. THE DEPLOYED STENT WAS THEN RE-CROSSED WITH AN INTRAVASCULAR ULTRASOUND PROBE, WHICH WAS POSITIONED IN THE DISTAL RIGHT CORONARY ARTERY. AUTOMATED PULLBACK OF THE INTRAVASCULR ULTRASOUND PROBE CATHETER WAS PERFORMED AT 0.5MM PER SECOND. INTRAVASCULAR ULTRASOUND REVEALED THAT THE MID AND DISTAL STENTED SEGMENT REVEALED AN ECCENTRIC PLAQUE AND THE STENT APPEARED TO BE MILDLY UNDERSIZED FOR THE VESSEL DIAMETER. WHEN AN ATTEMPT WAS MADE TO REMOVE THE INTRAVASCULAR ULTRASOUND CATHETER, IT BECAME APPARENT THAT THE INTRAVASCULAR ULTRASOUND CATHETER AND THE GUIDEWIRE WERE ENTANGLED WITH EACH OTHER. THEREFORE, THE GUIDE CATHETER, GUIDEWIRE AND INTRAVASCULAR ULTRASOUND CATHETER WERE REMOVED AS A UNIT. DURING THIS REMOVAL, A MODERATE DEGREE OF FORCE WAS REQUIRED. INSPECTION OF THE GUIDEWIRE REVEALED A KINK IN IT'S MID PORTION AND THE ULTRASOUND CATHETER HAD A KINK IN THE TRANSDUCER CABLE. UPON AN ATTEMPT TO POST DILATE THE STENT, IT WAS NOTED THAT IT NO LONGER REMAINED AT THE TARGET LESION SITE AND HAD MOST LIKELY MIGRATED INTO THE SYSTEMIC CIRCULATION. THEREFORE, A SECOND AVE STENT WAS SUCCESSFULLY DEPLOYED AT THE TARGET LESION SITE. THE PT DID NOT DEMONSTRATE ANY SYMPTOMS RELATED TO THE MIGRATED STENT AND REMAINED STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVE GFX OTW CORONARY STENT SYSTEM Implant OVER-THE-WIRE CORONARY STENT SYSTEM MAF ARTERIAL VASCULAR ENGINEERING, INC. NA 8K09E04

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention 2. NITROGLYCERIN,| 1. 5000 UNITS OF HEPARIN,| 3. CLOPIDOGREL,| 4. REOPRO.