BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 24818115 · Received April 8, 2026

    Report

    Report Number
    2024168-2026-01419
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    November 17, 2025
    Report Date
    April 8, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED, AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF OCCLUSION AND PAIN 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; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. D4: A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, TWO ESPRIT BTK SCAFFOLDS (SIZES 3.75X38, AND 3.0X28 MM) WERE IMPLANTED IN THE DISTAL LEFT ANTERIOR TIBIAL ARTERY. ON (B)(6) 2025, THE PATIENT WAS SEEN FOR A 30 DAY FOLLOW UP VISIT WITH COMPLAINTS OF LEFT FOOT PAIN. BOTH SCAFFOLDS WERE OCCLUDED. THE PATIENT HAS HAD NUMEROUS REVASCULARIZATIONS THAT HAVE QUICKLY FAILED. LEFT FEMORAL-TIBIAL BYPASS SURGERY WAS PERFORMED ON (B)(6) 2025, USING THE IPSILATERAL, REVERSED GREAT SAPHENOUS VEIN AS THE GRAFT. THE PATIENT HAD A STRONG PALPABLE PULSE IN THE OUTFLOW ARTERY AND MULTIPHASIC DOPPLER TONES, INCLUDING IN THE DORSALIS PEDIS OF THE FOOT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188591 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203375-38

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R