BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    MDR report key: 16503662 · Received March 8, 2023

    Report

    Report Number
    2024168-2023-02375
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    February 13, 2023
    Report Date
    May 22, 2023
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIO
    PMA / PMN Number
    P110043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL AND FUNCTIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED ACTIVATION FAILURE INCLUDING EXPANSION FAILURES WAS NOT 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 IDENTIFIED NO OTHER INCIDENTS. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED ACTIVATION FAILURE INCLUDING EXPANSION FAILURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. D4 - CATALOG #, LOT#, UDI UPDATED FROM (B)(4).

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ILIAC ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 80/ STENOSIS. THE 9X39MM OMNILINK ELITE BALLOON EXPANDABLE STENT FAILED TO DEPLOY. ANOTHER 9X29 OMNILINK ELITE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, THE ACCOUNT CONFIRMED THAT THE CORRECT DEVICE USED WAS A OMNILINK ELITE 9.0 X 29, PART NUMBER:11012-29, AND LOT# 2020441. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE ILIAC ARTERY WITH MILD CALCIFICATION, MILD TORTUOSITY AND 80/ STENOSIS. THE 9X39MM OMNILINK ELITE BALLOON EXPANDABLE STENT FAILED TO DEPLOY. ANOTHER 9X29 OMNILINK ELITE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136334 OMNILINK ELITE PERIPHERAL STENT SYSTEM PERIPHERAL STENT DELIVERY SYSTEM NIO ABBOTT VASCULAR 2020441

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown