BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 4221653 · Received November 3, 2014

    Report

    Report Number
    2024168-2014-07178
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 9, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)/. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (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. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. IT SHOULD BE NOTED THAT THE OTW OMNILINK ELITE INSTRUCTIONS FOR USE (IFU) STATES: CAREFULLY INSPECT THE OMNILINK ELITE PERIPHERAL STENT SYSTEM PRIOR TO USE TO VERIFY THAT THE STENT HAS NOT BEEN DAMAGED IN SHIPMENT AND THAT THE DEVICE DIMENSIONS ARE SUITABLE FOR THE SPECIFIC PROCEDURE. TAKE CARE TO AVOID UNNECESSARY HANDLING. ADDITIONALLY, THE IFU STATES: DO NOT ROLL THE MOUNTED STENT WITH YOUR FINGERS AS THIS ACTION MAY LOOSEN THE STENT FROM THE DELIVERY BALLOON. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE ADVANCING A 10 X 39 MM OMNILINK ELITE STENT DELIVERY SYSTEM THROUGH A 7F SHEATH, IT WAS NOTED THAT STENT SLIPPED PROXIMALLY. THE DEVICE WAS REMOVED FROM THE ANATOMY AND THE STENT WAS REPOSITIONED AND THEN HAND CRIMPED ON THE BALLOON. THE STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND THE STENT WAS SUCCESSFULLY DEPLOYED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702331 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 4020541

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: 7FR