BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 217721 · Received April 7, 1999

    Report

    Report Number
    2953200-1999-00032
    Event Type
    Injury
    Date Received
    April 7, 1999
    Date of Event
    March 5, 1999
    Report Date
    March 8, 1999
    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 8MM LENGTH AVE GFX STENT WAS INSERTED INTO A CORONARY ARTERY AFTER PREDILATION WITH A 3.0MM DIAMETER PTCA BALLOON. THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM WHILE ATTEMPTING TO TRACK TO THE TARGET LESION. THE STENT WAS SUCCESSFULLY RETRIEVED WITH A SNARE, AND THE TARGET LESION WAS THEN TREATED WITH ANOTHER MANUFACTURER'S STENT. IT IS NOT KNOWN IF THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR USE OF THE PRODUCT; HOWEVER, THERE IS NO PRODUCT COMPLAINT AND NO FURTHER INFORMATION 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 8L11E05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention