BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 23501439 · Received November 7, 2025

    Report

    Report Number
    2024168-2025-11423
    Event Type
    Malfunction
    Date Received
    November 7, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 7, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357176
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL ANTERIOR TIBIAL ARTERY WITH HEAVY TORTUOSITY AND NARROW STENOSIS THE 3.75X38 MM ESPRIT BELOW THE KNEE (BTK) SCAFFOLD SYSTEM BECAME STUCK ON A PIECE OF CALCIUM DURING ADVANCEMENT. WHEN THE DEVICE WAS INFLATED TO NOMINAL PRESSURE, THE BALLOON WAS NOTED TO BE RUPTURED. THE BALLOON AND DELIVERY SYSTEM WERE REMOVED AND THE STENT STAYED IN PLACE. POST DILATATION WAS PERFORMED PER STANDARD PROCEDURE. 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
    1925028 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203375-38 5081361 08717648357176

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown COMMAND 14.| TERUMO 45 CM SHEATH.