BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 23201713 · Received October 2, 2025

    Report

    Report Number
    2024168-2025-10687
    Event Type
    Injury
    Date Received
    October 2, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 2, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    PMA / PMN Number
    P230036
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT 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. THE REPORTED PATIENT EFFECT OF EMBOLISM IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. 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 ON (B)(6)2025, ONE 3.5X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE LEFT ANTERIOR TIBIAL ARTERY. ON (B)(6)2025 THE PATIENT WAS TO BE TREATED FOR THE OCCLUSION IN THE LEFT PERONEAL ARTERY, BUT THE GUIDEWIRE WAS UNABLE TO CROSS THE CHRONIC TOTAL OCCLUSION (CTO) IN THE MILDLY CALCIFIED TIBIOPERONEAL TRUNK. DURING THE ATTEMPT TO REACH THE TARGET LESION, THE GUIDEWIRE DISLODGED THE PROXIMAL MARKER FROM THE PREVIOUSLY IMPLANTED 3.5X38 ESPRIT BTK SCAFFOLD. THE MARKER MOVED TO THE CTO LESION AND REMAINED THERE. THE PREVIOUSLY IMPLANTED 3.5X38 ESPRIT BTK SCAFFOLD WAS NOTED TO BE WIDELY PATENT ON (B)(6)2025. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6)2025. REVIEW OF THE IMAGES FOUND THAT THE MARKER FROM THE PREVIOUSLY PLACED ESPRIT BTK 3.5 X 38 RX SCAFFOLD WAS NOTED AS MOVING FREELY IN THE ARTERY WHEN THE WIRE IS ADVANCED AND RETRACTED INTERACTING WITH THE PROXIMAL END OF THE SCAFFOLD. THE PROBABLE CAUSE OF THE MOVEMENT OF THE SCAFFOLD MARKER IS THE INTERACTION WITH THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459330 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 5031361

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other