BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 23254043 · Received October 9, 2025

    Report

    Report Number
    2024168-2025-11028
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 12, 2025
    Report Date
    October 9, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    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

    VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SHAFT DEFORMATION (KINK) WAS CONFIRMED. THE REPORTED DIFFICULTY/FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. A REVIEW OF THE PRODUCTION RECORD FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO RELATED MANUFACTURING NONCONFORMITIES. A QUERY OF THE COMPLAINT HANDLING SYSTEM FOR THE REPORTED LOT WAS PERFORMED AND REVEALED NO SIMILAR COMPLAINTS REPORTED FOR THIS LOT. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY 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 OPERATIONAL CONTEXT. 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 LESION IN THE LEFT POSTERIOR TIBIAL ARTERY. THE 3.50X38MM ESPRIT BTK SYSTEM WAS ADVANCED HOWEVER RESISTANCE WAS MET WITH THE TERUMO SHEATH DUE TO THE ANATOMY AND THE SYSTEM COULD NOT ADVANCE OVER THE ARCH IN THE ANATOMY. IT WAS NOTED THE SHAFT KINKED INSIDE THE SHEATH. THE SYSTEM WAS REMOVED WITHOUT ISSUE AND ANOTHER ESPRIT BTK WAS ADVANCED OVER A SPARTACORE GUIDE WIRE HOWEVER THE SAME ISSUE OCCURRED. THE DEVICE AND THE GUIDE WIRE WERE REMOVED WITHOUT ISSUE. THE PROCEDURE WAS ABORTED AT THAT POINT. NO FURTHER TREATMENT WAS PROVIDED. 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
    2574205 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 407126A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male