BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 23598242 · Received November 19, 2025

    Report

    Report Number
    2024168-2025-11611
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 13, 2025
    Report Date
    February 20, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357091
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED SHAFT KINK WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE CONFIRMED DUE TO THE CONDITION OF THE DEVICE WHEN RETURNED. 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 OF FAILURE TO ADVANCE AND SHAFT DEFORMATION APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BALLOON SHREDDING WAS OBSERVED DURING RETURN ANALYSIS OF THE DEVICE. IT IS UNCLEAR WHEN THIS DAMAGE OCCURRED AS THE ACCOUNT DID NOT REPORT SHREDDING. IT IS POSSIBLE THE BALLOON SHREDDING OCCURRED DUE TO FRICTION DURING TRANSIT POST PROCEDURE; 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 THE PROCEDURE PERFORMED WAS TO TREAT A POSTERIOR TIBIAL ARTERY. AN UNSPECIFIED ESPRIT BTK SCAFFOLD OVER A 0.014" GUIDE WIRE WAS DEPLOYED. A 3.50X38MM ESPRIT BTK RESORBABLE SCAFFOLD SYSTEM, WAS ADVANCED WHEN IT WAS OBSERVED THAT THE UNSPECIFIED 0.014" GUIDEWIRE WAS NO LONGER AT THE POSTERIOR TIBIAL ARTERY. THE GUIDE WIRE WAS ADJUSTED AND THE ESPRIT BTK PULLED BACK. AN ATTEMPT WAS MADE TO ADVANCE THE ESPRIT BTK; HOWEVER, UNSUCCESSFUL. THE ESPRIT BTK WAS REMOVED AND THE SHAFT WAS OBSERVED TO BE KINKED. THE FAILURE TO ADVANCE WAS NOTED TO BE DUE TO THE KINK IN THE DELIVERY SYSTEM OF THE ESPRIT BTK. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. RETURNED DEVICE ANALYSIS OBSERVED SHREDDING NOTED AT THE DISTAL BALLOON FOLDS AND THE GUIDE WIRE EXIT NOTCH WAS TORN DISTALLY FOR A LENGTH OF 5 MM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74869 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 5031361 08717648357091

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male