BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESPRIT¿

    MDR report key: 24500309 · Received March 3, 2026

    Report

    Report Number
    2024168-2026-00871
    Event Type
    Death
    Date Received
    March 3, 2026
    Date of Event
    November 27, 2025
    Report Date
    March 3, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357015
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. THE REPORTED DEATH WAS CONFIRMED TO NOT BE RELATED TO THE ESPRIT BTK DEVICE. NO DEVICE ISSUE OR PATIENT EFFECT RELATED TO THE DEVICE WAS REPORTED. 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. B5 - DESCRIBE EVENT OR PROBLEM: UPDATED AS ADDITIONAL INFORMATION WAS PROVIDED. H11 - ADDITIONAL MFR NARRATIVE: UPDATED AS ADDITIONAL INFORMATION WAS PROVIDED. CORRECTIONS: H6 - HEALTH EFFECT - CLINICAL CODE: CODE 4441 WAS REMOVED AND CODE 4582 WAS ADDED. H6 - HEALTH EFFECT - IMPACT CODE: CODE 1802 WAS REMOVED AND CODE 4657 WAS ADDED. H6 - MEDICAL DEVICE PROBLEM CODE: CODE 2993 WAS REMOVED AND CODE 3189 WAS ADDED.

    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 DEATH 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

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PRIMARY CAUSE OF DEATH IS LISTED AS CORONARY ARTERY DISEASE. THERE WERE NOT ANY NEW STENOSES IDENTIFIED PRIOR TO DEATH. IN THE PHYSICIAN'S OPINION, THE ESPRIT BTK DEVICE, DID NOT CAUSE A CARDIOVASCULAR DEATH OVER 8 MONTHS AFTER THE SCAFFOLD IMPLANTATION IN THE LOWER EXTREMITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 RIGHT ANTERIOR TIBIAL ARTERY. THE PATIENT WAS DISCHARGED HOME THE SAME DAY ON (B)(6) 2025. THE PATIENT EXPIRED ON (B)(6) 2025. THE DETAILS AROUND THIS ARE CURRENTLY UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289722 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203300-38 4080861 08717648357015

    Patients

    Seq Age Sex Outcome Treatment
    1