BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 177087 · Received July 15, 1998

    Report

    Report Number
    2953200-1998-00098
    Event Type
    Injury
    Date Received
    July 15, 1998
    Date of Event
    June 12, 1998
    Report Date
    June 15, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 24MM LENGTH AVE GFX STENT WAS INSERTED INTO THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION; THEREFORE, THE STENT AND DELIVERY SYS WERE PULLED BACK AND THE STENT DISLODGED FROM THE STENT DELIVERY SYS AT THE FEMORAL SHEATH. IT IS NOT KNOWN IF THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT. THE STENT WAS SUCCESSFULLY RETRIEVED FROM THE PT'S GROIN AND DISCARDED. THE TARGET LESION WAS TREATED WITH ANOTHER AVE GFX STENT SUCCESSFULLY. THERE WAS NO ADD'L 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 8F02E13

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention