BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 216939 · Received April 2, 1999

    Report

    Report Number
    2953200-1999-00031
    Event Type
    Injury
    Date Received
    April 2, 1999
    Date of Event
    March 3, 1999
    Report Date
    March 3, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 4.0MM DIAMETER X 18MM LENGTH AVE GFX STENT WAS INSERTED INTO THE OSTIAL CIRUCMFLEX CORONARY ARTERY AFTER PREDILATION WITH A 3.5MM DIAMETER PTCA BALLOON. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION DUE TO TORTUOSITY AND PROBLABLE INADEQUATE PREDILATION, THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY. UPON REMOVAL, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM. THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT, HOWEVER, THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED FOR PREDILATION OF THE TARGET LESION 1:1. THE STENT REMAINS WITHIN THE PT'S POPLITEAL ARTERY. THERE WAS NO ADD'L CLINICAL 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 8H20E01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention