BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 191638 · Received October 15, 1998

    Report

    Report Number
    2953200-1998-00144
    Event Type
    Injury
    Date Received
    October 15, 1998
    Date of Event
    August 27, 1998
    Report Date
    September 15, 1998
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE RIGHT CORONARY ARTERY (RCA) HAD DIFFUSE CORONARY ARTERY DIESEASE REQUIRING AGGRESSIVE PRE-TREATMENT WITH A PERCUTANEOUS BALLOON ALONG THE LENGTH OF THE ARTERY FROM THE DISTAL TO PROXIMAL LOCATIONS TO STENOSIS. A TOTAL OF FOUR AVE GFX STENTS WERE PLACED AT TARGET LESIONS IN THE POSTERIOR LATERAL BRANCH OF THE RIGHT CORONARY ARTERY AS WELL AS LESIONS IN THE DISTAL, MIDDLE AND PROXIMAL RIGHT CORONARY ARTERY. THE PROXIMAL STENT, A 3.0MM DIAMETER X 24MM LENGTH AVE GFX STENT, APPEARED TO HAVE A "GAP" IN THE SEGMENTS FOLLOWING MULTIPLE-POST DILATIONS TO ALL OF THE STENTS WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY BALLOON. SUBSEQUENTLY, ANOTHER AVE GFX STENT, 3.5MM DIAMETER X 8MM LENGTH WAS PLACED WITHIN THE PROXIMAL STENT TO COVER THE "GAP" IN THE SEGMENTS WITH GOOD RESULTS. THE INTERVENTION WAS DOCUMENTED AS SUCCESSFUL AND THERE WAS NO ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT.

    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 BG31E06

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention VERAPAMIL| MORPHINE| DIGOXIN| VERSED| LIDOCAINE