BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 23682231 · Received December 1, 2025

    Report

    Report Number
    2024168-2025-11805
    Event Type
    Injury
    Date Received
    December 1, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 1, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357251
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 PAIN IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED; HOWEVER, THE SUBSEQUENT TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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

    (B)(4). IT WAS REPORTED THAT ON (B)(6) 2025 ONE 2.5X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE LEFT POSTERIOR TIBIAL ARTERY. ON (B)(6) 2025 THE PATIENT HAD A PERSISTENT WOUND AND WORSENING ANKLE BRACHIAL INDEX AT THE FOLLOW UP VISIT. A LOWER LIMB ANGIOGRAM FOUND RESTENOSIS IN THE SUPERFICIAL FEMORAL ARTERY, POSTERIOR TIBIAL ARTERY AND ANTERIOR TIBIAL ARTERY. ANGIOPLASTY WAS PERFORMED IN THE RESTENOSIS. THE CONDITION RESOLVED WITHOUT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2135938 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203250-38 4081961 08717648357251

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Hospitalization| R