BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT¿

    MDR report key: 23487028 · Received November 6, 2025

    Report

    Report Number
    2024168-2025-11394
    Event Type
    Malfunction
    Date Received
    November 6, 2025
    Date of Event
    October 15, 2025
    Report Date
    January 22, 2026
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NXW
    UDI-DI
    08717648357015
    PMA / PMN Number
    P230036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

    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 OF SPECIFIC ISSUE. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED ISSUE APPEARS TO BE RELATED TO OPERATIONAL CONTEXT 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. CORRECTIONS: D9 - DEVICE AVAILABLE FOR EVALUATION: UPDATED FROM YES TO NO. H6 - MEDICAL DEVICE PROBLEM CODE: CODE 1562 WAS REMOVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TARGET VESSEL, POSTERIOR TIBIAL ARTERY, WAS TREATED WITH ORBITAL ATHERECTOMY AND PREDILATED WITH A 3.0 MM BALLOON DILATATION CATHETER. THE BALLOON WAS INFLATED TO 8 ATMOSPHERES. THE VESSEL WAS SIZED WITH INTRAVASCULAR ULTRASOUND (IVUS). THE PHYSICIAN WAS TRYING TO DELIVER THE 3.0X38 MM ESPRIT BTK OVER THE .014 VIPERWIRE GUIDEWIRE TO THE POSTERIOR TIBIAL ARTERY, BUT MET RESISTANCE WITH HEAVY CALCIUM AND HEAVY TORTUOSITY. THE DELIVERY SYSTEM OF THE ESPRIT KINKED DURING THE ATTEMPT TO ADVANCE THROUGH THE HEAVILY CALCIFIED/TORTUOUS ANATOMY. THE DEVICE CATHETER WAS FLIMSY AND WOULD NOT TRACK TO THE LESION, AND WAS UNABLE TO CROSS. NO DAMAGE WAS NOTED TO THE .014 VIPERWIRE GUIDEWIRE; HOWEVER, THE PHYSICIAN MET WITH RESISTANCE WHEN REMOVING THE ESPRIT BTK DEVICE FROM THE ANATOMY. OUTSIDE OF THE BODY, THE SHAFT OF THE DEVICE SNAPPED IN HALF WHERE IT HAD KINKED. IT IS REPORTED TO BE IN TWO SEPARATE PIECES. THE SEPARATION OCCURRED OUTSIDE THE PATIENT ANATOMY. THERE WERE NO ADVERSE PATIENT EFFECTS. THEY COMPLETED THE PROCEDURE WITHOUT A SCAFFOLD. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE ENTIRE ESPRIT BTK WAS REMOVED FROM THE PATIENT IN ONE PIECE. AFTER REMOVAL, THE SHAFT SEPARATED IN TWO PIECES AT THE LOCATION OF THE KINK. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2637908 ESPRIT¿ SCAFFOLD,INFRAPOPLITEAL,ABSORBABLE NXW ABBOTT VASCULAR INC. 1203300-38 5051461 08717648357015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown GUIDEWIRE: 014 VIPERWIRE| SHEATH: 6F 65 CM COOK