BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 3936018 · Received July 15, 2014

    Report

    Report Number
    2024168-2014-04531
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED DEPLOYMENT DIFFICULTY COULD NOT BE CONFIRMED AS THE STENT IMPLANT WAS NOT RETURNED. CINE REVIEW WAS PERFORMED AND CONFIRMED THE DIFFICULTY DEPLOYING THE STENT. 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. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS REPORTED FOR DIFFICULT TO DEPLOY. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. 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 MILDLY TORTUOUS MID FEMORAL ARTERY. DIRECT STENTING WAS PERFORMED WITH A 10 X 39 MM OMNILINK ELITE STENT. DURING DEPLOYMENT, THE STENT EXPANDED ON THE PROXIMAL END FIRST AND THEN IT TOOK LONGER FOR THE DISTAL STENT TO EXPAND. THE STENT DID NOT OPEN TO THE NOMINAL DIAMETER. POST-DILATATION WAS PERFORMED WITH A 10 X 40 MM UNKNOWN BALLOON CATHETER. 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
    414179 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 4030642

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SHEATH: 7F