BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 195622 · Received November 6, 1998

    Report

    Report Number
    2953200-1998-00153
    Event Type
    Injury
    Date Received
    November 6, 1998
    Report Date
    October 7, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 24MM LENGTH AVE GFX STENT WAS INSERTED INTO A CORONARY ARTERY. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION, THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY. DURING REMOVAL OF THE UNDEPLOYED STENT, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM. IT IS NOT KNOWN IF THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT, AND THERE IS NO PRODUCT COMPLAINT. THE STENT WAS SUCCESSFULLY SNARED FROM THE PATIENT. SUBSEQUENTLY, ANOTHER AVE GFX STENT WAS DEPLOYED AT THE TARGET LESION SITE, SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE WELL, AND THERE WAS NO ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. NO ADDITIONAL INFORMATION 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 8H07E12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention