BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 220165 · Received April 23, 1999

    Report

    Report Number
    2953200-1999-00035
    Event Type
    Injury
    Date Received
    April 23, 1999
    Date of Event
    March 24, 1999
    Report Date
    March 25, 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 3.0MM DIAMETER X 18MM LENGTH AVE GFX STENT WAS INSERTED INTO THE CIRCUMFLEX CORONARY ARTERY AFTER PREDILATION WITH A 2.5MM DIAMETER PTCA BALLOON. PREDILATION RESULTED IN SUBOPTIMAL RESULTS WITH A 30% RESIDUAL STENOSIS AND SOME HAZINESS. 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 IN THE LEFT MAIN CORONARY ARTERY. THE DISLODGED STENT WAS SNARED FROM THE CORONARY ARTERY SUCCESSFULLY. THE PHYSICIAN DID NOT FOLLOW THE INSTRUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT WHEN THE STENT WAS PULLED INTO THE GUIDE CATHETER. THERE WERE NO FURTHER ATTEMPTS TO CROSS THE TARGET LESION; THEREFORE THE LESION WAS LEFT WITH ANGIOPLASTY RESULTS ONLY AND TREATMENT OF "HAZINESS" WITH REO-PRO. THERE WERE NO ADDITIONAL CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT, AND THERE IS NO PRODUCT COMPLAINT FROM THE PHYSICIAN.

    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 8L18E09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention