BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 24756905 · Received April 1, 2026

    Report

    Report Number
    2024168-2026-01342
    Event Type
    Injury
    Date Received
    April 1, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 1, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357473
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. B3: DATE OF EVENT ESTIMATED. THE ADDITIONAL DEVICE MENTIONED IN B5 WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2025 WHERE TWO 3.50X28 ESPRIT BTK SCAFFOLDS WERE IMPLANTED OVERLAPPING IN THE ANTERIOR TIBIAL ARTERY WITHOUT ISSUE. PATIENT HAD GOOD INFLOW AFTER IMPLANTATION WITH GOOD OUTFLOW TO THE FOOT. AT THE THREE MONTH FOLLOW UP IT WAS NOTED BOTH OF THE SCAFFOLDS HAD OCCLUDED. NO TREATMENT WAS PERFORMED AS THE WOUND WAS ALREADY HEALING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472268 ESPRIT¿ STENT, INFRAPOPLITEAL, ABSORBABLE NXW ABBOTT VASCULAR INC. ESPRIT BTK 5080661 08717648357473

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other