BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 23531502 · Received November 12, 2025

    Report

    Report Number
    2024168-2025-11475
    Event Type
    Malfunction
    Date Received
    November 12, 2025
    Date of Event
    November 3, 2025
    Report Date
    November 12, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648356995
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. IT SHOULD BE NOTED THAT THE ESPRIT BTK INSTRUCTIONS FOR USE STATES: DO NOT USE AFTER THE ¿USE BY¿ DATE. THE VIOLATION RELATED TO USE AFTER EXPIRATION WAS RECOGNIZED AND REPORTED BY THE ACCOUNT. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO USER ERROR. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. H6 MEDICAL DEVICE PROBLEM CODE: 2017 - USE AFTER EXPIRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE ANTERIOR TIBIAL ARTERY. THE 3.0X28MM ESPRIT BTK SYSTEM WAS INSPECTED PRIOR TO USE AND IT WAS NOTED THE DEVICE EXPIRED ON 6/06/2025. THE PHYSICIAN ACKNOWLEDGED THE EXPIRATION HOWEVER DECIDED TO IMPLANT THE SCAFFOLD ANYWAY. THE DEVICE WAS USED WITHOUT ISSUE. 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
    1980449 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203300-28 4060761 08717648356995

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown