BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 184542 · Received August 28, 1998

    Report

    Report Number
    2953200-1998-00127
    Event Type
    Injury
    Date Received
    August 28, 1998
    Date of Event
    July 20, 1998
    Report Date
    July 30, 1998
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.5MM DIAMETER X 30MM LENGTH AVE GFX STENT WAS INSERTED INTO THE RIGHT CORONARY ARTERY OF A PT WITH MULTI-VESSEL CORONARY DISEASE. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION, THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY. DURING REMOVAL, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM. THE STENT WAS SUCCESSFULLY SNARED FROM THE PT AND DISCARDED. SUBSEQUENTLY, THE PT WENT TO SURGERY FOR REPAIR OF THE FEMORAL ARTERY. IS IS NOT KNOWN IF THE REPAIR TO THE FEMORAL ARTERY IS ASSOCIATED WITH THE USE OF AN AVE GFX STENT, BUT THE PT "DID NOT SUFFER ANY FURTHER INJURY". 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 8F25E17

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention