BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 4921706 · Received July 17, 2015

    Report

    Report Number
    2024168-2015-03978
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    April 23, 2015
    Report Date
    September 28, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS AND WAS INVESTIGATED. A COMPLETE ANALYSIS WAS UNABLE TO BE PERFORMED, AS THE DEVICE WAS RETURNED IN A CONDITION THAT PREVENTED ADVANCEMENT OF THE DELIVERY SYSTEM INTO THE SHEATH. A REVIEW OF THE LOT HISTORY RECORD WAS CONDUCTED AND FOUND NO EXCEPTIONS ASSOCIATED WITH THIS LOT DURING MANUFACTURING. A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE OBSERVED ISSUE APPEARS TO BE RELATED TO AN OPERATIONAL PROBLEM THAT CAN CONTRIBUTE TO THE STENT DISRUPTION THAT COULD CAUSE INTERFERENCE BETWEEN THE SHEATH AND THE STENT DELIVERY SYSTEM. THE PERFORMANCE OF THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER OMNILINK ELITE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED MID ILIAC ARTERY. A 10 X 39 MM OMNILINK (LOT #4011441) WAS BEING ADVANCED THROUGH A NON-ABBOTT 6F SHEATH WHEN IT BECAME STUCK IN THE SHEATH. IT WAS REMOVED WITHOUT INCIDENT, SO AN ATTEMPT WAS MADE WITH A SECOND 10 X 39 MM OMNILINK ELITE (LOT #3021541); HOWEVER, WHEN IT WAS ADVANCED THROUGH THE SAME NON-ABBOTT 6F SHEATH, IT ALSO BECAME STUCK AND WHEN ATTEMPTING TO REMOVE THE CATHETER, THE STENT IMPLANT DISLODGED IN THE SHEATH. THE STENT WAS REMOVED FROM THE ANATOMY WITH THE SHEATH. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PHYSICIAN COMMENTED THAT THERE WAS AN ISSUE WITH THE COMPATIBILITY OF THE OMNILINK AND THE 6F SHEATH. THE BOX LABEL STATES A 6F SHEATH IS COMPATIBLE AND THE IFU ON THE WEBSITE STATES A 7F SHEATH IS COMPATIBLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467129 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 4011441

    Patients

    Seq Age Sex Outcome Treatment
    1