BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 22577718 · Received July 23, 2025

    Report

    Report Number
    2024168-2025-07599
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 23, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357251
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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 WAS NOTED THAT THE 2.5X38 MM ESPRIT SCAFFOLD WAS EXPIRED. THE PHYSICIAN WAS AWARE BUT DEPLOYED THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE ESPRIT BTK INSTRUCTIONS FOR USE STATES: DO NOT USE AFTER THE ¿USE BY¿ DATE. 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 THAT THE PROCEDURE WAS TO TREAT THE RIGHT PERONEAL ARTERY WITH MILD CALCIFICATION AND 99% STENOSIS. THE 2.5X38 MM ESPRIT BELOW THE KNEE (BTK) BIORESORBABLE VASCULAR SCAFFOLD (BVS) WAS IMPLANTED IN THE DISTAL PERONEAL AND A 3.0X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED MORE PROXIMALLY. IT WAS NOTED THAT THE 2.5X38 MM ESPRIT SCAFFOLD WAS EXPIRED. THE PHYSICIAN WAS AWARE BUT DEPLOYED THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2784591 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203250-38 4061961 08717648357251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown