BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 23817395 · Received December 16, 2025

    Report

    Report Number
    2024168-2025-12075
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357091
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT POSTERIOR TIBIAL ARTERY. A NON-ABBOTT FILTRATION DEVICE WAS PLACED IN THE VESSEL AND ATHERECTOMY PERFORMED. THE 3.50X35MM ESPRIT BTK SYSTEM WAS ADVANCED AND THE SCAFFOLD DEPLOYED IN THE TARGET LESION WITH THE SCAFFOLD WELL APPOSED TO THE VESSEL WALL. DURING ADVANCEMENT OF THE FILTRATION DEVICE RETRIEVAL CATHETER, IT BECAME CAUGHT ON THE IMPLANTED SCAFFOLD STRUTS. THE SCAFFOLD WAS PUSHED FURTHER DOWN THE ARTERY BUT WAS IN THE INTENDED LESION STILL AND DID NOT STRETCH. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAYS IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1662148 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 5091061 08717648357091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SPIDER FILTER