BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 23192216 · Received October 1, 2025

    Report

    Report Number
    2024168-2025-10531
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 1, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 EFFECT OF OCCLUSION IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEMS INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, 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

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025, ONE 3.0X38 MM ESPRIT BTK SCAFFOLD WAS IMPLANTED IN THE LEFT PROXIMAL POSTERIOR TIBIAL ARTERY (PTA). ON (B)(6) 2025, THE PATIENT HAD A LOWER LIMB ANGIOGRAM AS A PART OF STANDARD OF CARE. A NEAR COMPLETE OCCLUSION OF THE PROXIMAL PTA (INDEX STUDY LESION) WAS NOTED. GIVEN THE RISK OF DISTAL EMBOLIZATION WITH ATTEMPTING TO RECANALIZE THE PROXIMAL PTA, THE PHYSICIAN ELECTED NOT TO TREAT. THE CONDITION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674367 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203300-38 4090461

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| O