BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 23827778 · Received December 17, 2025

    Report

    Report Number
    2024168-2025-12126
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    December 4, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648353864
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 DISSECTION AND OCCLUSION ARE LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEM INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY SCAFFOLDING 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED TOTALLY OCCLUDED LESION IN THE RIGHT POSTERIOR TIBIAL ARTERY. A 2.50X38MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE DISTAL LESION FOLLOWED BY TWO 3.0X38MM IMPLANTED IN THE PROXIMAL LESION. NO ISSUES WERE NOTED DURING DEPLOYMENT OF THE SCAFFOLDS AND ALL THREE WERE CONFIRMED TO BE WELL APPOSED TO THE VESSEL WALL. POST IMPLANT, NO FLOW WAS NOTED TO THE FOOT. THE LESION WAS REWIRED AND BALLOON ANGIOPLASTY AND THROMBECTOMY WERE PERFORMED HOWEVER OUTFLOW WAS NOT ABLE TO BE ESTABLISHED. PER THE PHYSICIAN, THERE WAS POSSIBLE EMBOLIZATION FROM THE PROCEDURE OR DISSECTION OF THE DISTAL VESSEL. THE PATIENT REMAINED HOSPITALIZED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186298 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. ESPRIT¿ 5050561 08717648353864

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Hospitalization| R