BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 205149 · Received January 8, 1999

    Report

    Report Number
    2953200-1999-00004
    Event Type
    Malfunction
    Date Received
    January 8, 1999
    Date of Event
    June 1, 1998
    Report Date
    December 7, 1998
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    Z-676/677-8
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.5MM DIAMETER X 18MM LENGTH AVE GFX STENT WAS INSERTED AND PLACED ACROSS THE TARGET LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. UPON ATTEMPT TO INFLATE STENT DELIVERY SYSTEM TO 9 ATM., THE BALLOON DID NOT EXPAND. ANOTHER ATTEMPT WAS MADE TO INFLATE THE BALLOON TO 15 ATM. AND THE BALLOON STILL WOULD NOT INFLATE. 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 8E14E11

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other