BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 23283898 · Received October 15, 2025

    Report

    Report Number
    2024168-2025-11074
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    August 23, 2025
    Report Date
    October 13, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357015
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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. THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE OF CORONARY STENTING PROCEDURES. 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

    IT WAS REPORTED THAT THE 3.0X38 MM ESPRIT BELOW THE KNEE (BTK) SCAFFOLD WAS IMPLANTED ON (B)(6) 2025 IN THE 100% OCCLUDED PERONEAL ARTERY AFTER INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO SIZE THE VESSEL. THE PATIENT HAD REDNESS AND A NON-HEALING WOUND ON (B)(6) 2025. THE PATIENT WAS TREATED FOR THROMBOSIS IN THE SCAFFOLD ON (B)(6) 2025. THE PATIENT WAS NOT COMPLIANT WITH DAPT AND HAD NOT FILLED THE MEDICATION UNTIL ONE MONTH AFTER IMPLANT. BALLOON ANGIOPLASTY WAS PERFORMED AND A CORONARY STENT WAS PLACED. THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483394 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203300-38 408136A 08717648357015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R