BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 22809835 · Received August 14, 2025

    Report

    Report Number
    2024168-2025-08499
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 14, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357091
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 KINK (DEFORMATION DUE TO COMPRESSIVE STRESS) WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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 FAILURE TO ADVANCE COULD NOT BE DETERMINED. THE REPORTED SHAFT KINK APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. THE SKIVE SEPARATION AND OUTER MEMBER DAMAGE (TORN OUTER MEMBER) WAS NOT REPORTED BY THE ACCOUNT AS PART OF THE PROCEDURE. FOLLOW UP WITH THE ACCOUNT CONFIRMED THAT THEY WERE UNAWARE OF THE OBSERVED DAMAGE INDICATING IT IS DUE TO POST PROCEDURE HANDLING DURING PACKAGING FOR RETURN ANALYSIS. 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 LESION IN THE SUPERFICIAL FEMORAL ARTERY. FOLLOWING ATHERECTOMY AND THE DEPLOYMENT OF UNSPECIFIED STENTS, A 3.5X38MM ESPRIT BTK WAS ATTEMPTED TO BE ADVANCED; HOWEVER, THE DEVICE ONLY MADE IT HALFWAY THROUGH THE LESION AND FAILED TO CROSS AND THE SHAFT KINKED. IT IS UNKNOWN WHY THE DEVICE FAILED TO CROSS BECAUSE AN UNSPECIFIED BALLOON CATHETER HAD ALREADY CROSSED SUCCESSFULLY PRIOR TO THE ATTEMPT TO CROSS THE ESPRIT BTK. A SECOND 3.5X38MM ESPRIT BTK WAS THEN ADVANCED, THROUGH RESISTANCE, AND SUCCESSFULLY DEPLOYED AND POST-DILATED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS REVEALED THAT THE SUPPORT SKIVE/WIRE/BAYONET SEPARATED BUT HELD TOGETHER BY THE OUTER MEMBER. THE ACCOUNT CONFIRMED THE CORRECT DEVICE WAS RETURNED, AND NOTED THAT THEY WERE UNAWARE OF THE DAMAGES FOUND IN THE PRODUCT RETURN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866547 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 4082661 08717648357091

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male