BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 220017 · Received April 22, 1999

    Report

    Report Number
    2953200-1999-00034
    Event Type
    Injury
    Date Received
    April 22, 1999
    Date of Event
    February 2, 1999
    Report Date
    March 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 24MM LENGTH AVE GFX STENT WAS INSERTED INTO THE CORONARY ARTERY. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION, THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK INTO THE TIP OF THE GUIDE CATHETER, WHERE IT CAUSED THE STENT TO DISLODGE FROM THE STENT DELIVERY SYSTEM BALLOON. THE DISLODGED STENT WAS SNARED FROM THE CORONARY ARTERY SUCESSFULLY. THE PHYSICIAN DID NOT FOLLOW THE INSTRUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT WHEN THE STENT WAS PULLED INTO THE GUIDE CATHETER. TWO STENTS FROM ANOTHER MFR WERE SUBSEQUENTLY INSERTED, BUT ONLY THE SECOND ONE CROSSED THE LESION AND WAS DEPLOYED SUCCESSFULLY. THERE WAS NO ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT, AND THERE IS NO FURTHER INFO AVAILABLE 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 8H14E24

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention HEPARIN (10000U), NITROGLYCERIN, MORPHINE.