BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 224221 · Received May 21, 1999

    Report

    Report Number
    2953200-1999-00047
    Event Type
    Injury
    Date Received
    May 21, 1999
    Date of Event
    April 13, 1999
    Report Date
    April 23, 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 4.0MM DIAMETER X 18MM LENGTH AVE GFX STENT WAS INSERTED AND DEPLOYED AT THE TARGET LESION SITE IN THE CIRCUMFLEX ARTERY. THE STENT WAS DEPLOYED AT 8 ATMS OF PRESSURE AND THEN RE-INFLATED TO 16 ATMS BECAUSE THE PHYSICIAN FELT THAT THE STENT WAS UNDER-SIZED FOR THE VESSEL INNER DIAMETER. AT 16 ATMS, WHICH EXCEEDS "RATED" BURST PRESSURE OF 9 ATMS, THE BALLOON BURST WITHIN THE STENT. AFTER REMOVAL OF THE STENT DELIVERY SYSTEM FROM THE PT, IT WAS NOTED THAT A PORTION OF THE BALLOON MATERIAL REMAINED WITHIN THE PT. THE BALLOON MATERIAL WAS SUCCESSFULLY SNARED FROM THE CORONARY ARTERY, AND THE PT IS DOING FINE. THERE WAS NO ADDITIONAL 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 8L20E22

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention