BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 167609 · Received May 15, 1998

    Report

    Report Number
    2953200-1998-00073
    Event Type
    Injury
    Date Received
    May 15, 1998
    Date of Event
    April 16, 1998
    Report Date
    April 16, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 15MM LENGTH AVE GEX STENT WAS INSERTED INTO A TORTUOUS CIRCUMFLEX ARTERY AFTER PREDILATION WITH A 2.5MM DIAMETER PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY BALLOON. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION DUE TO THE INABILITY TO CROSS AN ACUTE BOND LOCATED PROXIMAL TO THE TARGET LESION. THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY. UPON REMOVAL, THE STENT DISLODGED FROM STENT DELIVERY SYSTEM AT THE PROXIMAL ACUTE BEND IN THE ARTERY. STENT RETRIEVAL FROM THE CORONARY ARTERY WAS UNSUCCESSFUL, AND THROMBUS BEGAN TO DEVELOP IN THE ARTERY. THE ACTIVATED CLOTTING TIME AT THIS TIME WAS 102 SECONDS. SUBSEQUENTLY, THE PT REMAINED STABLE AND WAS SENT TO CORONARY BYPASS SURGERY. THE SURGERY WAS SUCCESSFUL, AND 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| R