BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 10309995 · Received July 22, 2020

    Report

    Report Number
    2024168-2020-06120
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 22, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION; HOWEVER, THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS. 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 IDENTIFIED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. POSSIBLE FACTOR THAT MAY CONTRIBUTE TO LABELING PROBLEMS OR LOT MIX-UPS CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, MANUFACTURING, SHIPPING, OR LOT MIX-UP AT THE ACCOUNT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DEVICE MARKING ISSUE/LABELING PROBLEM. IT IS POSSIBLE THAT A MIX-UP OCCURRED AT THE HOSPITAL DURING A PREVIOUS PROCEDURE. IT IS POSSIBLE THAT THE OTW OMNI LINK ELITE 11013-39 / 0010941 AND OTW OMNI LINK ELITE 35 11013-39 / 9070841 DEVICES WERE PULLED OFF THE SHELF AND OPENED FOR USE IN A PREVIOUS SURGICAL PROCEDURE. THE OTW OMNI LINK ELITE 35 11013-39 / 0010941 DEVICE WAS REMOVED FROM THE CLIPBOARD BOX BUT NOT USED AND ACCIDENTLY PLACED INSIDE THE OTW OMNI LINK ELITE 35 11013-39 / 9070841 CLIPBOARD BOX AT THE END OF THE PROCEDURE, THEN INADVERTENTLY BEEN PLACED BACK ON THE SHELF; HOWEVER, THIS COULD NOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 10.0X39 MM OMNI LINK ELITE STENT WAS IMPLANTED SUCCESSFULLY. AFTER IMPLANTATION IT WAS NOTED THAT THE LOT NUMBER OF THE INNER POUCH WAS DIFFERENT FROM THE LOT ON THE OUTER PACKAGING. ON THE INNER POUCH WAS LOT 0010941, OUTER PACKAGING WAS 9070841. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770738 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT DELIVERY SYSTEM NIO ABBOTT VASCULAR 0010941

    Patients

    Seq Age Sex Outcome Treatment
    1