BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 23662772 · Received November 26, 2025

    Report

    Report Number
    2024168-2025-11794
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 9, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648356995
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    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 OF 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 PERFORMED TO TREAT A HEAVILY CALCIFIED, MILDLY TORTUOUS PERONEAL ARTERY THAT IS 80-90% STENOSED. TWO NON-ABBOTT GUIDE WIRES WERE ADVANCED, ONE IN THE POSTERIOR TIBIAL AND OTHER IN THE PERONEAL ARTERY. A 3.0X28MM ESPRIT BELOW THE KNEE (BTK) STENT DELIVERY SYSTEM WAS ATTEMPTED TO ADVANCE TO THE PERONEAL ARTERY; HOWEVER, FAILED AS THE DELIVERY SYSTEM MET RESISTANCE WITH GUIDE WIRE IN THE POSTERIOR TIBIAL ARTERY. DURING REMOVAL OF THE ESPRIT BTK DELIVERY SYSTEM RESISTANCE WAS MET WITH THE GUIDE WIRE AND THE SHAFT OF THE ESPRIT BTK WAS NOTED TO ACCORDION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2782232 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203300-28 501206A 08717648356995

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown