BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK OTW VISION CORONARY STENT SYSTEM

    MDR report key: 4171348 · Received October 14, 2014

    Report

    Report Number
    2024168-2014-06693
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT'S AGE WAS ESTIMATED. THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULT TO POSITION AND REMOVE THE GUIDE WIRE COULD NOT BE CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON THE VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS OF THE DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NON-ABBOTT GUIDE WIRE WAS ADVANCED TO THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. A VISION STENT DELIVERY SYSTEM WAS ADVANCED OVER THE GUIDEWIRE AND RESISTANCE AND WAS MET BEFORE ENTERING THE ANATOMY. THE RESISTANCE WAS WITH THE GUIDEWIRE. THE SAME VISION WAS RE-ADVANCED. THE SAME RESISTANCE WAS MET, BUT NOT AS MUCH AS BEFORE. THE VISION WAS THEN UNABLE TO CROSS THE LESION. THE VISION WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE VISION WAS STUCK ON THE GUIDE WIRE. THE NON-ABBOTT GUIDE WIRE AND VISION WERE REMOVED AS A SINGLE UNIT WITHOUT ISSUE. THE PATIENT WAS RE-WIRED AND ANOTHER 3.0X23MM VISION WAS IMPLANTED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650616 MULTI-LINK OTW VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT 3073141

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR