BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 23612147 · Received November 20, 2025

    Report

    Report Number
    2024168-2025-11679
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 4, 2025
    Report Date
    December 29, 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

    VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SHAFT SEPARATION WAS CONFIRMED. THE REPORTED DIFFICULTY TO ADVANCE AND DIFFICULTY TO REMOVE COULD NOT BE CONFIRMED DUE TO THE CONDITION THE DEVICE WAS 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 REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES 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. MEDICAL DEVICE PROBLEM CODE 2017: EXCESSIVE FORCE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS CAPTURED UNDER A SEPARATE MEDWATCH NUMBER.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS STATED THAT THE DEVICES BECAME STUCK AND COULD NOT BE ADVANCED OR REMOVED FROM EACH OTHER PRIOR TO THE ESPRIT BEING ADVANCED INTO THE ANATOMY. FORCE WAS USED DURING REMOVAL OF THE DEVICES FROM EACH OTHER WITHOUT REMOVING THE WIRE OUT OF THE ANATOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANTERIOR TIBIAL ARTERY WITH NO CALCIFICATION OR TORTUOSITY NOTED. AN ESPRIT BTK SCAFFOLD WAS IMPLANTED EARLIER IN THE PROCEDURE. THE 2.5X38 MM ESPRIT BTK SCAFFOLD SYSTEM WAS ATTEMPTED TO BE ADVANCED ON THE COMMAND 14 GUIDE WIRE; HOWEVER, ALTHOUGH THE WIRE WAS WIPED, THE DEVICES HAD RESISTANCE AND COULD NOT BE ADVANCED OR REMOVED. THE DEVICES WERE REMOVED TOGETHER AND THE ESPRIT SHAFT SEPARATED WHEN THE DEVICES WERE REMOVED FROM THE ANATOMY. AT THIS POINT THE LESION WAS IMAGED AGAIN AND DUE TO THE GOOD FLOW NOTED, NO ADDITIONAL PROCEDURE WAS PERFORMED. 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
    293987 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203250-38 5090261 08717648357251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown COMMAND 14 GUIDE WIRE.