BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 23873053 · Received December 22, 2025

    Report

    Report Number
    2024168-2025-12215
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 22, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357091
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 EFFECTS OF STENOSIS 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; 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 3.50X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE LEFT ANTERIOR TIBIAL ARTERY. DUPLEX ULTRASOUND FROM (B)(6) 2025 SHOWED SEVERE STENOSIS IN THE ANTERIOR TIBIAL ARTERY. ON (B)(6) 2025 THE PATIENT WAS SEEN FOR HIS 180-DAY FOLLOW-UP VISIT AND WAS NOTED TO HAVE DECREASED LOWER LIMB PULSES. ANGIOGRAM SHOWED THAT THERE WAS 90% STENOSIS PROXIMAL TO THE STUDY DEVICE IN THE ANTERIOR TIBIAL ARTERY. LASER ATHERECTOMY AND ANGIOPLASTY WERE PERFORMED IN THE LEFT ANTERIOR TIBIAL ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786325 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 5012761 08717648357091

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Hospitalization| R