BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 187446 · Received September 16, 1998

    Report

    Report Number
    2953200-1998-00137
    Event Type
    Injury
    Date Received
    September 16, 1998
    Date of Event
    August 17, 1998
    Report Date
    August 19, 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
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.5MM DIAMETER X 18MM LENGTH AVE GFX STENT WAS INSERTED INTO THE CORONARY ARTERY. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION, THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY. UPON REMOVAL, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM AT THE FEMORAL ARTERIAL SHEATH. IT IS NOT KNOWN IF THE PHYSICIAN FOLLOWED THE INSTUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT. THE STENT REMAINS WITHIN THE PATIENT'S PERIPHERAL VASCULATURE. SUBSEQUENTLY, ANOTHER GFX STENT WAS PLACED AT THE TARGET LESION, SUCCESSFULLY. THE DOCTOR HAS NO PRODUCT COMPLAINT 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 8G15E13

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention