BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 6846734 · Received September 6, 2017

    Report

    Report Number
    2024168-2017-07319
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 3, 2017
    Report Date
    October 31, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PART NUMBER HAS BEEN CHANGED FROM 1012630-59 TO 1012623-59. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED RESISTANCE WAS NOT CONFIRMED BECAUSE THE INTRODUCER SHEATH WAS NOT RETURNED AND THE STENT WAS DAMAGED. THE UNSTABLE STENT WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT REVEALED NO OTHER INCIDENTS. THE INVESTIGATION WAS UNABLE TO DETERMINE CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. 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 AN ILIAC ARTERY. THE 7.0 X 59 MM OTW OMNILLINK ELITE STENT DELIVERY SYSTEM COULD NOT ADVANCE THROUGH THE INTRODUCER SHEATH. ANOTHER SAME SIZE OMNILINK ELITE WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THE STENT HAD MOVED DISTALLY ON THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624402 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT SYSTEM NIO AV-TEMECULA-CT 6032141

    Patients

    Seq Age Sex Outcome Treatment
    1