BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT¿

    MDR report key: 24944456 · Received April 21, 2026

    Report

    Report Number
    2024168-2026-01628
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648353864
    PMA / PMN Number
    P230036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 PATIENT EFFECT OF OCCLUSION IS LISTED IN THE ESPRIT BTK EVEROLIMUS ELUTING RESORBABLE SCAFFOLD SYSTEM OVER-THE-WIRE (OTW) INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT OF CORONARY SCAFFOLDING PROCEDURES. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, 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. THE OTHER SCAFFOLDS REFERENCED IN B5 ARE BEING FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 0

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2025 THREE ESPRIT OTW SCAFFOLDS (SIZES 2.5X38, 3.0X38 (X2) MM) WERE IMPLANTED IN THE PROXIMAL RIGHT ANTERIOR TIBIAL ARTERY. DURING A FOLLOW-UP APPOINTMENT ON (B)(6) 2026, THE PATIENT HAD BILATERAL CYANOSIS AND NON-PALPABLE PULSES. THE PATIENT WAS SCHEDULED FOR AN ANGIOGRAM TO TREAT A LOWER LIMB ARTERIAL OCCLUSION (STENOSIS) IN ALL THREE INDEX SCAFFOLDS. ON (B)(6) 2026, HE UNDERWENT SUCCESSFUL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF THE TARGET ANTERIOR TIBIAL ARTERY, WHICH IMPROVED FROM 100% STENOSIS TO RESTORED PATENCY AND FLOW. THE PROCEDURE RESTORED PERFUSION WITHOUT COMPLICATION, AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30430 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1212250-38 5050561 08717648353864

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Hospitalization| R TWO ESPRIT OTW SCAFFOLDS, SIZED 3.0X38 MM