BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 23843500 · Received December 18, 2025

    Report

    Report Number
    2024168-2025-12162
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357091
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    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. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE AS IT IS LIKELY THE REPORTED INTERACTION WITH GUIDE WIRE (OR ANY OTHER PROCEDURAL ACCESSORY) CONTRIBUTED TO THE REPORTED STRETCHED SCAFFOLD. 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 WAS TO TREAT A TOTALLY OCCLUDED LESION IN THE RIGHT ANTERIOR TIBIAL ARTERY. A NON-ABBOTT BALLOON WAS USED FOR PRE-DILATATION UP AND DOWN THE LESION BUT A PART OF IT DID NOT OPEN. THE JADE BALLOON WAS USED TO OPEN THE LESION SOME MORE AND AN ORBITAL ATHERECTOMY SYSTEM (OAS) WAS ALSO USED. THREE ESPRIT BTK STENTS WERE IMPLANTED TO THE DISTAL PORTION OF THE RIGHT ANTERIOR TIBIAL ARTERY WITHOUT ISSUES. THE 3.5X38MM ESPRIT BTK STENT WAS THEN IMPLANTED TO THE PROXIMAL PORTION SUCCESSFULLY. HOWEVER, GUIDEWIRE ACCESS WAS LOST. A NEW NON-ABBOTT GUIDEWIRE WAS ATTEMPTED TO GAIN ACCESS BUT FAILED EVEN WITH THE AID OF A .018 SUPPORT CATHETER. DURING THIS TIME, THE IMPLANTED SCAFFOLD WAS NOTED TO HAVE STRETCHED STILL WITHIN THE TARGET LESION UPON FLUOROSCOPY, AND THE MARKERS WERE INTACT. IT WAS NOTED THAT EITHER UNSPECIFIED GUIDEWIRE OR THE MICRO CATHETER DAMAGED THE SCAFFOLD. NO INTERVENTION WAS PERFORMED, AND THE PROCEDURE WAS ABORTED SINCE GUIDEWIRE ACCESS COULD NOT BE RE-ESTABLISHED. 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
    2386086 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203350-38 5091061 08717648357091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 0.018 QUICKCROSS SUPPORT CATHETER.| CHOICE PT FLOPPY GUIDEWIRE, 0.018 QUICKCROSS SUPPO.