BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE MICRO STENT II OTW CORONARY STENT SYSTEM

    MDR report key: 183095 · Received August 19, 1998

    Report

    Report Number
    2953200-1998-00120
    Event Type
    Injury
    Date Received
    August 19, 1998
    Report Date
    July 21, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 30MM LENGTH AVE MICRO STENT II WAS INSERTED INTO THE RIGHT CORONARY ARTERY, AFTER PRE-TREATMENT WITH ROTATIONAL ATHERECTOMY. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION DUE TO RESIDUAL STENOSIS, THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY. DURING REMOVAL, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM. THE STENT WAS SNARED FROM THE PT AND THE TARGET LESION WAS TREATED WITH SUCCESSFUL PLACEMENT OF ANOTHER STENT. IT IS NOT KNOWN IF THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT. THERE WAS NO ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT AND NO FURTHER INFO AVAILABLE FROM THE USER FACILITY.

    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 8D10E07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention