BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 4760616 · Received May 8, 2015

    Report

    Report Number
    2024168-2015-02627
    Event Type
    Malfunction
    Date Received
    May 8, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 16, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR DEVICE EXPIRATION ISSUES REPORTED FROM THIS LOT. IT SHOULD BE NOTED THAT THE MULTI-LINK VISION CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: NOTE THE PRODUCT USE BY DATE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE MARGINAL ARTERY, AFTER DEVICE PREPARATION, THE VISION STENT DELIVERY SYSTEM WAS BEING BACKLOADED ONTO THE GUIDE WIRE LOCATED IN THE ANATOMY WHEN IT WAS NOTED THE DEVICE WAS EXPIRED. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INTERACTION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A SECOND VISION STENT WAS USED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303033 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 2041341

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR