BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 2853031 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07578
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT DISLODGEMENT WAS ABLE TO BE CONFIRMED; HOWEVER, THE INFLATION DIFFICULTIES WERE UNABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE OMNILINK ELITE VASCULAR BALLOON EXPANDABLE STENT SYSTEM INSTRUCTIONS FOR USE STATES: THE OMNILINK ELITE STENT SYSTEM IS INDICATED FOR THE TREATMENT OF ATHEROSCLEROTIC ILIAC ARTERY LESIONS. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A LESION IN THE SUBCLAVIAN ARTERY, PRE-DILATATION WAS PERFORMED USING AN UNSPECIFIED 8 MM DILATATION CATHETER. THE OMNILINK ELITE STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY AND TO THE TARGET LESION. THE STENT DELIVERY SYSTEM BALLOON WAS INFLATED; HOWEVER, ONLY THE DISTAL END OF THE BALLOON INFLATED AND THE STENT WAS PUSHED PROXIMALLY, ONTO THE SHAFT OF THE STENT DELIVERY SYSTEM. AN ATTEMPT WAS MADE TO REMOVE THE DEVICE, BUT THE STENT CAME OFF THE STENT DELIVERY SYSTEM AND DISLODGED IN THE SUBCLAVIAN ARTERY AND EXTENDED INTO THE AORTA. THE STENT DELIVERY SYSTEM WAS USED TO EXPAND THE STENT. ADDITIONAL DILATATION WAS PERFORMED USING A 10 X 30 X 135 MM NON-ABBOTT DILATATION CATHETER AND A 12 X 20 X 135 MM NON-ABBOTT DILATATION CATHETER TO FULLY APPOSE THE STENT TO THE VESSEL WALL AND FLARE THE PORTION OF THE STENT REMAINING IN THE AORTA. A NON-ABBOTT STENT WAS THEN IMPLANTED TO TREAT THE STENOSIS IN THE SUBCLAVIAN ARTERY. THERE WERE NO ADVERSE PATIENT SEQUELA; HOWEVER, THERE WAS A CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 2062041

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention