BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 23361518 · Received October 22, 2025

    Report

    Report Number
    2024168-2025-11199
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 22, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357015
    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

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED SHAFT DEFORMATION DUE TO COMPRESSIVE STRESS, TEAR AND SEPARATION WERE CONFIRMED. 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, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED; HOWEVER, POTENTIAL CAUSES FOR THE REPORTED SHAFT DAMAGE ( SHAFT BEND/KINKS, SHAFT TEAR AND SEPARATION) INCLUDE, BUT ARE NOT LIMITED TO, DAMAGE DURING MANUFACTURING, INADVERTENT MISHANDLING DURING UNPACKAGING, DURING PREPARATION OR USE OF THE DEVICE, INTERACTION WITH THE ANATOMY AND/OR ACCESSORY DEVICES. IN THIS CASE, IT IS POSSIBLE THAT INADVERTENT MISHANDLING WHILE REMOVING THE DEVICE FROM THE PROTECTIVE COIL MAY HAVE CONTRIBUTED TO THE REPORTED SHAFT KINK, TEAR AND SEPARATION; HOWEVER, THIS CANNOT BE CONFIRMED. 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 WHEN REMOVING THE 3.00X38MM ESPRIT BTK RESORBABLE SCAFFOLD SYSTEM FROM THE YELLOW SHEATH [DISPENSER COIL], THE SHAFT WAS NOTED TO BE KINKED. SHAFT DAMAGE (TEAR AND SEPARATION) WAS ALSO OBSERVED. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DEVICE USE OR PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445920 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203300-38 5052061 08717648357015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown