BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 22730577 · Received August 6, 2025

    Report

    Report Number
    2024168-2025-08127
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 1, 2025
    Report Date
    September 8, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357091
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 OCCLUSION IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEM INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY SCAFFOLDING 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. D4: CORRECTED LOT NUMBER FROM UNK TO 4081561 D4: CORRECTED PRIMARY UDI NUMBER FROM (B)(4).

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICES REFERENCED IN B5 ARE CAPTURED UNDER A SEPARATE MEDWATCH NUMBER. A PARTIAL UDI WAS PROVIDED BECAUSE THE LOT IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 3.5X18 MM, 3.5X38 MM, 3.75X18 MM AND A 3.75X38 MM ESPRIT BELOW THE KNEE (BTK) BIORESORBABLE VASCULAR SCAFFOLD WERE IMPLANTED ON (B)(6) 2025 IN THE RIGHT ANTERIOR TIBIAL ARTERY WITH HEAVY CALCIFICATION AND 100% STENOSIS. THE STENTS APPEARED OCCLUDED UNDER X RAY FROM (B)(6) 2025. TREATMENT WAS NOT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365126 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 4081561 08717648357091

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other 3.5X18 MM, 3.5X38 MM, 3.75X38 MM ESPRIT