BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 23829917 · Received December 17, 2025

    Report

    Report Number
    2024168-2025-12134
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    September 29, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357091
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 OCCLUSION IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY SCAFFOLDING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE.

    Description of Event or Problem · 0

    PATIENT ID: (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT UNDERWENT THE STUDY PROCEDURE WITH IMPLANT OF THE 2.5X38 MM ESPRIT BTK SCAFFOLD IN THE RIGHT PERONEAL ARTERY. THERE WAS NO RESIDUAL STENOSIS POST INDEX PROCEDURE. FOUR DAYS LATER, ON (B)(6) 2025 THE PATIENT WAS SEEN FOR HER ROUTINE DUPLEX ULTRASOUND WHICH FOUND 75-99% STENOSIS IN THE INDEX, MID ANTERIOR TIBIAL ARTERY, ALONG WITH SEGMENT OCCLUSION IN THE PROXIMAL, MID, AND DISTAL PERONEAL ARTERY. THE PATIENT DID NOT HAVE SYMPTOMS AND DID NOT HAVE NEW OR WORSENING WOUNDS; THEREFORE, NO INTERVENTION WAS INDICATED FOR THE OCCLUSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2274524 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 5060661 08717648357091

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other