BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 183083 · Received August 19, 1998

    Report

    Report Number
    2953200-1998-00119
    Event Type
    Injury
    Date Received
    August 19, 1998
    Date of Event
    July 20, 1998
    Report Date
    July 20, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 18MM LENGTH AVE GFX STENT WAS INSERTED INTO A CALCIFIED LESION IN THE CIRCUMFLEX ARTERY. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION DUE TO CALCIFICATION, THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK PARTIALLY INTO THE GUIDE CATHETER. THE GUIDE CATHETER AND STENT DELIVERY SYSTEM WERE THEN REMOVED AS A UNIT, HOWEVER, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM AT THE FEMORAL SHEATH. THE PHYSICIAN DID NOT FOLLOW THE INSTRUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT WHEN THE STENT WAS PULLED INTO THE GUIDE CATHETER. THE STENT WAS SUCCESSFULLY SNARED FROM THE PT. THERE WAS NO ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT AND THERE IS NO FURTHER INFO 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 8E29E11

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention