BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVE GFX OTW CORONARY STENT SYSTEM

    MDR report key: 220144 · Received April 23, 1999

    Report

    Report Number
    2953200-1999-00037
    Event Type
    Injury
    Date Received
    April 23, 1999
    Date of Event
    March 26, 1999
    Report Date
    March 26, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 30MM LENGTH AVE GFX STENT WAS INSERTED INTO THE RIGHT CORONARY ARTERY AFTER PREDILATION WITH A 3.0MM DIAMETER PTCA BALLOON. THE PT WAS 74 YEARS OLD WITH A HISTORY OF HYPERTENSION, DIABETES AND AN EJECTION FRACTION OF 30%. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION DUE TO CALCIFICATION; THEREFORE, THE STENT AND DELIVERY SYSTEM WERE PULLED BACK FROM THE CORONARY ARTERY. UPON REMOVAL, THE STENT WAS CAUGHT ON A CALCIFIED AREA OF THE TARGET VESSEL AND DISLODGED FROM THE STENT DELIVERY SYSTEM. THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT AND ATTEMPTED TO SNARE THE STENT, UNSUCCESSFULLY. THE PT WENT TO SURGERY FOR REMOVAL OF THE STENT AND CORONARY ARTERY BYPASS SURGERY. THE PHYSICIAN HAS NO PRODUCT COMPLAINT, AND THERE WAS NO ADDITIONAL CLINICAL SEQUELAE 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 74 YR Required Intervention 4. NITROGLYCERIN.| 2. VERSED,| 3. HEPARIN (11000U),| 1. ASPIRIN,