BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 188442 · Received September 23, 1998

    Report

    Report Number
    2953200-1998-00138
    Event Type
    Injury
    Date Received
    September 23, 1998
    Date of Event
    August 22, 1998
    Report Date
    August 24, 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 3.0MM DIAMETER X 30MM LENGTH AVE GFX STENT WAS INSERTED INTO THE CIRCUMFLEX CORONARY ARTERY OF UNK MORPHOLOGY. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION POSSIBLY DUE TO NO PREDILATION OF THE TARGET LESION, THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY. UPON REMOVAL, THE STENT WAS DISPLACED HALFWAY OFF OF THE STENT DELIVERY SYSTEM BALLOON AND WAS SURGICALLY REMOVED FROM THE PT. IT IS NOT KNOWN IF THE PHYSICIAN FOLLOWED THE INSTUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT, HOWEVER, THE INSTRUCTIONS WERE NOT FOLLOWED FOR PREDILATION OF THE TARGET LESION. THE TARGET LESION WAS SUBSEQUENTLY TREATED WITH ANOTHER STENT, SUCCESSFULLY. THERE WAS ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT AND NO FURTHER INFO 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 8G28E11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention