BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 4243387 · Received November 11, 2014

    Report

    Report Number
    2024168-2014-07330
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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 ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE RIGHT COMMON FEMORAL ARTERY. PRE-DILATATION WAS PERFORMED WITH AN UNSPECIFIED 3.0X20MM BALLOON DILATATION CATHETER (BDC). AN UNSPECIFIED ATHERECTOMY DEVICE FAILED TO CROSS THE LESION DUE TO INTERACTIONS WITH THE PATIENT'S ANATOMY. ADDITIONAL PRE-DILATATION WAS PERFORMED WITH A 2.5X20MM UNSPECIFIED BDC. ANOTHER UNSPECIFIED ATHERECTOMY DEVICE FAILED TO CROSS THE LESION DUE TO INTERACTIONS WITH THE PATIENT'S ANATOMY. THE 8.0MMX39MMX80CM OMNILINK ELITE STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE LESION DUE TO INTERACTIONS WITH THE PATIENT'S ANATOMY AND THE STENT IMPLANT DISLODGED. ATTEMPTS TO SNARE THE DISLODGED STENT IMPLANT WERE UNSUCCESSFUL; THEREFORE, A NON-ABBOTT STENT IMPLANT WAS DEPLOYED TO EMBED THE DISLODGED OMNILINK ELITE STENT IMPLANT AGAINST THE VESSEL WALL IN HEALTHY TISSUE. THE TARGET LESION WAS TREATED WITH AN UNSPECIFIED ATHERECTOMY DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726122 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 4071041

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention