BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 22916593 · Received August 28, 2025

    Report

    Report Number
    2024168-2025-09221
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 28, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357176
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED DIFFICULTY REMOVE AND SCAFFOLD DAMAGE (EXPLANTED) WAS CONFIRMED DUE TO THE RETURNED GUIDE WIRE STILL ATTACHED TO THE EXPLANTED SCAFFOLD. 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. BASED ON THE REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT MILDLY CALCIFIED TIBIOPERINEAL ARTERY. AFTER PRE-DILATION, A 3.75X38MM ESPRIT BTK DRUG-ELUTING RESORBABLE SCAFFOLD SYSTEM WAS IMPLANTED. AFTER IMPLANTATION, POST-DILATION WAS PERFORMED AND UPON REMOVAL, THE SCAFFOLD GOT STUCK TO THE TIP OF THE INTERVENTIONAL WIRE AND THE ESPRIT SCAFFOLD WAS EXPLANTED. AN UNSPECIFIED STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2075187 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203375-38 4110661 08717648357176

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female