BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 3944656 · Received July 18, 2014

    Report

    Report Number
    2024168-2014-04629
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED STENT DISLODGMENT WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE AND DIFFICULT TO REMOVE COULD NOT BE REPLICATED IN A LAB ENVIRONMENT AS IT WAS BASED ON CASE CIRCUMSTANCES. BASED ON VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES OR EXCEPTIONS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE COMMON ILIAC ARTERY. A 6F SHEATH WAS USED AND THE 8.0X39MM OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT SYSTEM WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS RETRACTED AND THE STENT BECAME STUCK HALFWAY INTO THE SHEATH. THE OMINLINK AND THE SHEATH WERE REMOVED TOGETHER AS ONE UNIT; HOWEVER, UPON REMOVAL, THE STENT WAS FOUND TO BE DISLODGED IN THE RIGHT COMMON FEMORAL ARTERY, STICKING HALFWAY INTO THE SOFT TISSUE. A 5F SHEATH WAS PLACED THROUGH THE STENT AND A MINI CUT DOWN WAS PERFORMED. A 6MM BALLOON WAS USED TO CONTROL BLEEDING DURING THE CUT DOWN. THE SHEATH AND STENT WERE REMOVED SUCCESSFULLY WITH HEMOSTATS AND THE PROCEDURE WAS STOPPED. A CLINICALLY SIGNIFICANT DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422663 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 4042941

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention