BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 222325 · Received May 10, 1999

    Report

    Report Number
    2953200-1999-00042
    Event Type
    Injury
    Date Received
    May 10, 1999
    Date of Event
    March 19, 1999
    Report Date
    April 8, 1999
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    TWO STENTS HAD BEEN PREVIOUSLY PLACED AT THE TARGET LESION SITE ON AN ACUTE BEND IN THE RIGHT CORONARY ARTERY RESULTING IN DISSECTION AND THROMBUS LOCATED DISTAL TO THE MOST DISTAL STENT. A PTCA BALLOON WAS INSERTED, BUT WAS NOT ABLE TO CROSS THE DEPLOYED STENTS. DESPITE THE INABILITY OF THE PTCA BALLOON TO CROSS, A 3.0MM DIAMETER X 8MM LENGTH AVE GFX STENT WAS THEN INSERTED INTO THE EXCESSIVELY TORTUOUS RIGHT CORONARY ARTERY FOR ATTEMPTED PLACEMENT AT THE DISTAL DISSECTION, BUT WAS ALSO NOT ABLE TO CROSS THE PREVIOUSLY DEPLOYED STENTS. THE UNDEPLOYED STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY TO THE FEMORAL SHEATH, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE OF THIS PRODUCT. HOWEVER, UPON ATTEMPTED RETRACTION OF THE STENT INTO THE FEMORAL SHEATH, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM. IT WAS NOT POSSIBLE TO DETERMINE THE LOCATION OF THE STENT, WHICH REMAINS WITHIN THE PT'S ARTERIAL VASCULATURE.... SUBSEQUENTLY, THE PT WAS TREATED WITH REOPRO AND IS DOING FINE. THERE WAS NO ADDITIONAL SEQUELAE REPORTED RELATIVE TO THE EVENT, AND NO FURTHER INFO IS AVAILABLE FROM THE USER FACILITY.

    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 8L16E16

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention