BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 24766806 · Received April 2, 2026

    Report

    Report Number
    2024168-2026-01355
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 2, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648353703
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. FACTORS THAT MAY CONTRIBUTE TO THE TEMPERATURE INDICATOR BEING TRIGGERED INCLUDE, BUT ARE NOT LIMITED TO, MANUFACTURING, STORAGE ENVIRONMENT, OR TRANSPORTATION METHOD. THE TEMPERATURE MONITOR IS CONFIGURED WITH ALARMS THAT ARE TRIGGERED WHEN A TEMPERATURE THRESHOLD IS EXCEEDED. THERE IS NO EVIDENCE THAT SUGGESTS THE THERMO ALERTS DO NOT FUNCTION AS INTENDED; THEREFORE, THERE IS NO PRODUCT QUALITY CONCERN. IT IS POSSIBLE THAT THESE DEVICES EXPERIENCED TEMPERATURE EXCURSIONS AS THEY WERE NOT STORED IN A TEMPERATURE MONITORED ROOM. 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. THE ADDITIONAL DEVICE MENTIONED IN B5 WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A CALCIFIED LESION IN THE PROXIMAL ANTERIOR TIBIAL ARTERY. IT WAS NOTED DURING PREPARATION THAT THE TEMPERATURE TAGS ON THE 3.50X38MM ESPRIT BTK AND 3.75X38MM ESPRIT BTK SYSTEMS WERE TRIGGERED. THE DEVICES WERE NOT CORRECTLY STORED IN A TEMPERATURE MONITORED ROOM. THE SCAFFOLDS WERE IMPLANTED IN THE PATIENT 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
    15206 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. ESPRIT¿ 5042861 08717648353703

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male