BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE MICRO STENT II OTW CORONARY STENT SYSTEM

    MDR report key: 226159 · Received June 9, 1999

    Report

    Report Number
    2953200-1999-00052
    Event Type
    Injury
    Date Received
    June 9, 1999
    Date of Event
    March 6, 1998
    Report Date
    May 11, 1999
    Manufacturer
    ARTERIAL VASCULAR ENGINEERING, INC.
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 4.0MM DIAMETER X 24MM LENGTH AVE MICRO STENT II WAS INSERTED INTO THE CORONARY ARTERY AND DEPLOYED. UPON INFLATION OF THE STENT DELIVERY SYSTEM BALLOON TO 14 ATMS, WHICH EXCEEDS "RATED BURST" PRESSURE OF 9 ATMS, THE BALLOON BURST WITHIN THE STENT. THE ENTIRE SYSTEM: GUIDE CATHETER, STENT DELIVERY SYSTEM BALLOON AND GUIDEWIRE WERE THEN REMOVED AS A SYSTEM WITH RESISTANCE NOTED BY THE PHYSICIAN. AFTER REMOVAL OF THE BALLOON FROM THE PT, IT WAS NOTED THAT PART OF THE BALLOON MATERIAL WAS MISSING. IT WAS NOT POSSIBLE TO LOCATE THE MISSING BALLOON MATERIAL WITHIN THE GUIDE CATHETER; THEREFORE, THE BALLOON MATERIAL MAY BE WITHIN THE PT'S ARTERIAL VASCULATURE. THE PT REMAINED ASYMPTOMATIC AND WAS SENT TO SURGERY FOR CORONARY ARTERY BYPASS PLACEMENT. THERE WAS NO ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT, AND NO FURTHER INFO IS AVAILABLE FROM THE USER FACILITY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVE MICRO STENT II OTW CORONARY STENT SYSTEM Implant OVER-THE-WIRE CORONARY STENT SYSTEM MAF ARTERIAL VASCULAR ENGINEERING, INC. NA 8A12E03

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR