BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 23846312 · Received December 18, 2025

    Report

    Report Number
    2024168-2025-12167
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    September 20, 2025
    Report Date
    January 28, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357091
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    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(S) OF HYPERSENSITIVITY IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), 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; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD AN ESPRIT BELOW THE KNEE IMPLANTED IN THE RIGHT TIBIOPERINEAL TRUNK ARTERY. TWO DAYS LATER THE PATIENT BEGINS TO EXPERIENCE PURPURA (RASH, ALLERGIC REACTION). A STEROID SHOT WAS ADMINISTERED; HOWEVER, THE PATIENT IS STILL EXPERIENCING PURPURA LEG, ARMS AND TRUNK. THE PATIENT NEVER LISTED ANY ALLERGIES OR STATED ANY ALLERGY TESTING HAS BEEN DONE. THE PATIENT IS BEING SEEN BY THE PHYSICIAN FOR RE-EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD AN ESPRIT BELOW THE KNEE IMPLANTED IN THE RIGHT TPT TRUNK. TWO DAYS LATER THE PATIENT BEGINS TO EXPERIENCE PURPURA (RASH, ALLERGIC REACTION). A STEROID SHOT WAS ADMINISTERED; HOWEVER, THE PATIENT IS STILL EXPERIENCING PURPURA LEG, ARMS AND TRUNK. THE PATIENT NEVER LISTED ANY ALLERGIES OR STATED ANY ALLERGY TESTING HAS BEEN DONE. THE PATIENT IS BEING SEEN BY THE PHYSICIAN FOR RE-EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259133 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 5021761 08717648357091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other