BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 24203072 · Received January 28, 2026

    Report

    Report Number
    2024168-2026-00394
    Event Type
    Malfunction
    Date Received
    January 28, 2026
    Date of Event
    January 7, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357251
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A VISUAL INSPECTION AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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. B5: DESCRIBE EVENT OR PROBLEM: THE PROCEDURE DESCRIPTION WAS UPDATED. D4: CORRECTED LOT NUMBER FROM UNKNOWN TO 5052961. D4: CORRECTED PRIMARY UDI NUMBER FROM (B)(4) TO (B)(4). H6: CORRECTED MEDICAL DEVICE PROBLEM CODE 2923 WAS REMOVED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: A PARTIAL UDI WAS PROVIDED AS THE LOT NUMBER IS NOT KNOWN.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIALLY FILED REPORT IT WAS REPORTED THAT THE FIRST ESPRIT WAS A 2.5X38 MM AND WAS NOT DISLODGED. THE SECOND ESPRIT HAD DIFFICULTY ADVANCING TO THE LESION BUT WAS ULTIMATELY ADVANCED AND IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION WITH CALCIFICATION AND A DISSECTION PRESENT. THE 3.5X38 MM ESPRIT BTK DELIVERY SYSTEM WAS ATTEMPTED TO BE ADVANCED BUT FAILED TO CROSS THE LESION POTENTIALLY DUE TO A PRE-EXISTING DISSECTION FLAP BUT THE REASON IS UNKNOWN. IT WAS NOTED THAT THE DISTAL END OF THE STENT WAS PARTIALLY COMING OFF OF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED AND A 3.0X38 MM ESPRIT BTK DELIVERY SYSTEM WAS THEN ATTEMPTED BUT THIS DEVICE ALSO DID NOT CROSS, POTENTIALLY DUE TO THE DISSECTION FLAP. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84416 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203250-38 5052961 08717648357251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown