BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 3964781 · Received July 29, 2014

    Report

    Report Number
    2024168-2014-04841
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    May 21, 2014
    Report Date
    July 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION AND THE REPORTED DIFFICULTY WAS CONFIRMED. BASED ON VISUAL AND FUNCTIONAL 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 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 IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 70% STENOSED, HEAVILY CALCIFIED LESION IN THE MILDLY TORTUOUS ILIAC ARTERY. THE 9.0MMX39MMX80CM OMNILINK ELITE 35 STENT IMPLANT WAS SUCCESSFULLY DEPLOYED; HOWEVER, DURING WITHDRAWAL OF THE OMNILINK ELITE 35 STENT DELIVERY SYSTEM, RESISTANCE WAS MET WITH THE NON-ABBOTT INTRODUCER SHEATH. ALL DEVICES WERE REMOVED AS A SINGLE UNIT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS 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
    442496 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 2030242

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: ARROW REF CL-07645